Six-month clinical outcome of cyclosporine microemulsion formulation (Sigmasporin Microral) in stable renal transplant patients previously maintained on sandimmun neoral.

The trial objective was to investigate the feasibility and safety of conversion to a generic microemulsion cyclosporine in stable renal transplant patients premaintained on Neoral. We enrolled 75 patients from seven centers in five Middle Eastern countries monitored them for 6 months after conversion to Sigmasporin Microral. Readings at 0, 0.5, 1, 2, 3, 4.5, and 6 months included cyclosporine blood level, serum creatinine, liver enzymes, lipid profile, blood sugar, blood pressure and adverse events. Patients included 54 men and 21 women of mean age 38.9 +/- 10.7 years at 30.3 +/- 29.3 months post-transplantation maintained on Sigmasporin Microral dose of 2.8 +/- 1.0 mg/kg per day; they were observed to be stable throughout the study period as reflected by the therapeutic blood C0 level of 181.6 +/- 102.1 and C2 of 759.2 +/- 384.4. Their absorption profile as represented by C2/C0 was 4.9 +/- 2.8, and C2/cyclosporine dose of 282.3 +/- 128.8. An average serum creatinine level of 116.1 +/- 29.5 micromol/L denoted stable graft function and their liver enzymes did not change during the study. No new-onset cases of hypertension, diabetes mellitus, or hyperlipidemia were reported among the patients. Graft function was stable for all patients, except for two incidences of mild acute rejection and two of mild cyclosporine nephrotoxicity; graft and patient survival rates were both 100%. Results of this 6-month study showed that Sigmasporin Microral was effective to maintain stable renal function in kidney transplant patients converted from Neoral with similar safety and tolerability profiles as those reported in the literature.

Therapeutic equivalence and mg:mg switch ability of a generic cyclosporine microemulsion formulation (Sigmasporin Microral) in stable renal transplant patients maintained on Sandimmun Neoral.

We tested a hypothesized pharmacokinetic difference between the reference (Sandimmun Neoral) and test (Sigmasporin Microral) products to prove therapeutic equivalence in an open, multiple fixed dose, one-way crossover, multicenter, and multinational study over a period of 29 days. Forty two stable renal transplant recipients maintained on Sandimmun Neoral were enrolled. Whole blood was collected at day 14 of the study at 0, 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after reference dosing and the same schedule was repeated at day 29 after switching on an mg:mg basis to the test product at day 15 of the study. Analysis of variance was performed for the pharmacokinetic parameters (area under the curve [AUC]0-12, maximum concentration [Cmax]) of cyclosporine using log-transformed values. Tolerability was assessed by vital signs, adverse events, and laboratory investigations. The 90% confidence interval (CI) test for the Ln-transformed, pharmacokinetic parameters was all within the US Food and Drug Administration acceptable range of 80% to 125%, as Ln area under the steady-state curve (AUCss) was within the range of 92.56 to 103.55 and Ln Cmax was within the range of 85.73 to 103.58; the same also applied for AUC0-4, which may be considered the area of greatest inter- and intra-patient variability. Furthermore, in line with the newly adopted recommendations of the Expert Advisory Committee on Bioavailability and Bioequivalence of Health Canada, the 90% CI for AUCss was within the narrow range of 90% to 112%. No significant difference in tolerability was recorded between the two products. Sigmasporin Microral (Julphar) was found to be bioequivalent and clinically interchangeable on an mg:mg basis with Sandimmun Neoral (Novartis).

Serum cystatin C in pregnant women: reference values, reliable and superior diagnostic accuracy.

BACKGROUND: A simple, endogenous, accurate and minimally invasive marker of glomerular filtration rate (GFR) is much desired in clinical nephrology. Cystatin C fulfills all criteria to be a marker for GFR. For early detection of renal impairment in pregnant women, it is necessary to determine serum cystatin C reference values and the correlation with GFR. The present study was therefore undertaken. METHOD: Healthy pregnant women were followed during pregnancy and the postnatal period. Patient demographics included age, height, weight, BMI, parity, total blood count, LFT, urea, creatinine, Na, K, and blood sugar. Serum cystatin C was estimated using particle enhanced nephlo-immunoassay method. All the parameters were recorded at the start of pregnancy and then in each trimester and the postnatal period. Regression analysis correlation coefficient, ANOVA and the Student's t-test were used for analysis using the SPSS statistical package. RESULTS: A total of 197 pregnant women were included. Mean serum cystatin C for all the women was 0.82 +/- 0.184 mg/l. Serum cystatin C levels were high -0.89 +/- 0.12 mg/l in the first trimester, decreased significantly to 0.651 +/- 0.14 mg/l during the second trimester (p = 0.0000 compared to first trimester), and increased again to 0.82 +/- 0.191 mg/l in the third trimester. After delivery the level rose to 0.94 +/- 0.12 mg/l. A strong correlation was found between serum cystatin C and serum creatinine. A strong negative correlation was found between GFR and cystatin C values in the women (r = -0.546, p = 0.000). A linear relationship was found between GFR and cystatin C levels. A significant increase in the GFR was noted with the progression of pregnancy from 128.06 +/- 29.7 ml/min in the first trimester to 155.2 +/- 29.59 ml/min during second trimester (p = 0.006). A decline in the level of cystatin C exactly parallel to the increase in the GFR was noted with the progression of pregnancy. Interestingly cystatin C was found to have a strong negative correlation with gestational age (r = -0.663, p = 0.000). CONCLUSION: Our results indicate that the mean serum cystatin C levels reflect changes in the GFR during the entire pregnancy and also in the postnatal period. Moreover, serum cystatin C levels are independent of age, height, weight, or blood sugar level. Cystatin C can be used for close supervision and early diagnosis of renal impairment in pregnant patients. Cystatin C is a reliable, useful and promising marker of GFR in pregnant women.

Role of interferon-alpha in the treatment of primary glomerulonephritis.

Interferon-alpha (IFN-alpha) is a naturally occurring cytokine. It was the first cytokine used with clinical benefit in the treatment of viral hepatitis and malignancies. Patients with viral hepatitis B or C may have complications with glomerulonephritis (GN). Improvement in proteinuria with or without clearing of viral markers after IFN-alpha therapy has been reported. This encouraged us to offer IFN-alpha therapy to four patients with GN. These patients refused treatment with steroids and/or cyclophosphamide because of concerns about side effects. One patient with membranous GN and two patients with mesangial GN (MesGN) had a remission of nephrotic syndrome. In one patient with type II diabetes and MesGN, renal insufficiency and proteinuria did not subside; however, renal function remained stable. The mechanism of action of IFN-alpha is discussed, with its possible role in the treatment of primary GN.

The new rHuEPO alpha (epotin) in the management of anemia of end-stage renal disease in patients on maintenance hemodialysis.

Recombinant human erythropoietin has proved to be effective to treat anemia of end-stage renal disease (ESRD). The aim of this study was to assess the efficacy and safety profile of Epotin, a rHuEPO produced in the Middle East. One hundred thirty patients with Hct

Prevalence of infection from subclavian dialysis catheters with two different postinsertion catheter cares: a randomized comparative study.

A comparison of the outcome of two different protocols concerning the postinsertion catheter care are reported and the literature of the subject is reviewed. Forty patients had the "Quinton" double-lumen catheter in the subclavian vein for hemodialysis. These catheters were kept in place for a total of 1392 days. The patients were divided randomly into two groups (A and B), each consisting of 20 patients. The care of group A catheters was done by the hospital intravenous (IV) team using heparin flushing three times/day. The care of group B catheters was done by dialysis nurses using heparin 1 mL of 2500 units in each lumen only after dialysis, ie, three times/week. The bacteremia rate of group A was 15% while that of group B was 5%. In conclusion, flushing the catheter with heparin 1 mL/2500 units in each lumen of the catheter at the end of dialysis, ie, three times/week along with changing the dressing once per week were found valuable in decreasing the rate of bacteremia from catheter infection.

Dual-lumen femoral vein catheterization as vascular access for hemodialysis--a prospective study.

Prospectively from January 1991 to January 1993, the efficacy and complications of 104 polyurethane, double-lumen femoral vein catheterizations (FVC) in 96 renal failure patients were studied. Ambulation was allowed in the hospital as well as at home while the catheter was in. There were 53 males and 43 females, with ages ranging from 13 to 87 (mean, 48.3 +/- 19.7) years. Forty-eight patients had chronic renal failure and 48 had acute renal failure. The catheters were used for 1 to 26 days (mean, 8 +/- 5 days). Fifty-two (50%) of the FVC were used for 2 weeks and 14 (13.5%) for 3 weeks or longer. The various complications encountered were infection (n=31), poor blood flow (n=8), displaced catheter (n=6), thrombosis of the catheter (n=4), hematoma (n=4), bleeding (n=3), exit site infection (n=3), ileofemoral vein thrombosis (n=2), and tear in the catheter wall (n=2). On removal, bacterial colonization was present in 34 out of 93 catheter tips (36.5%); Staphylococcus epidermidis (n=12) was the commonest organism grown. There was no significant difference of infection between diabetic and nondiabetic chronic renal failure patients. The duration of catheterization was found to have no relation with either thrombosis or infection. Femoral vein catheters can be used for hemodialysis for 2 to 3 weeks and ambulation during cannulation may be allowed.

Outcome of early ambulation after renal biopsy using automated biopsy needle by inexperienced trainees.

Percutaneous renal biopsy is a fundamental diagnostic technique. Technical innovations had resulted in an increasing simplicity and safety of the procedure. In this study, 28 kidney biopsies were done using gauge 16 or 18 automated biopsy needle by inexperienced trainees, and patients were allowed full ambulation four hours after biopsy. The trainees failed in 3 (10.7%) attempts. Adequate biopsy was obtained in 89.3%, the mean number of attempts were 2.5 +/- 1.1 (range 1-6/biopsy). The mean length of specimen was 1.5 cm +/- 0.6 (range 0.4-3 cm) and the mean number of glomeruli was 12.8 +/- 7 (range 12-30 glomeruli). Immediately and twenty-four hours after kidney biopsy patients showed no evidence of gross haematuria and ultrasound did not reveal any intrarenal and perirenal haematoma. Microscopic haematuria occurred in 20 (71.4%) patients on the first day and in only 7 (25%) patients the following day. Pain had occurred in 8 (28.5%) patients post-biopsy and in 4 (14.2%) patients on the second day.

Hypercholesterolemia in healthy adult males - A public survey in central Saudi Arabia.

To describe hypercholesterolemia in an urban community in Saudi Arabia, total serum cholesterol (TSC) was measured in 966 apparently healthy males (475 Saudi Arabs, 351 other Arabs and 140 non-Arabs) using a portable analyzer (Boehringer Model[R]). Mean age was 35.9 years (SD+/-9.1) and mean body mass index (BMI) was 26.2 kg/m(2) (SD+/-3.4) with a mean TSC of 5.20 mmol (SD+/-1.21). Mean TSC was significantly higher among non-Arabs at 5.74 mmol/L (SD+/-1.48) than in Saudi Arabs at 4.93 mmol/L (SD+/-1.11), P<0.001 mmol/L. TSC was higher than 5.20 mmol/L in 44.3% and higher than 6.80 mmol/L in 6.9% of the population. TSC was higher than 6.80 mmol/L in 3.6% of Saudi Arabs, 8.0% in other Arabs and 15.7% in the non-Arabs. This calls for cholesterol screening of the indigenous male population for hypercholesterolemia and other coronary heart disease risk factors at every opportunity. Among expatriate males, a mass screening strategy might be appropriate. The health care system needs appropriate adjustment to deal with this growing health problem.

The pattern of diabetic nephropathy among Saudi patients with noninsulin-dependent diabetes mellitus.

There were no studies on the different stages of diabetic nephropathy in Saudi Arabia, particularly the earliest stages. We have therefore investigated the frequency of occurrence of varying degrees of proteinuria including microalbuminuria in noninsulin-dependent diabetes mellitus (NIDDM) Saudi patients as well as the correlation of varying degrees of proteinuria with other diabetic complications and risk factors. One hundred and twenty-five NIDDM patients were studied. Fifty-seven were males and 68 were females. Their mean age was 49.8 +/- 10 years with a mean duration of diabetes of 9.48 +/- 6 years. The mean of HbA1c was 10.3 +/- 2.6%, serum creatinine was 76.7 +/- 23 mmol/L, creatinine clearance 94.3 mL/min, glomerular filtration rate 129.7 +/- 44 and effective renal plasma flow was 496.5 +/- 153. The pattern of proteinuria group was as follows: nephrotic range proteinuria 5.6%, clinical proteinuria 30.4%, microalbuminuria 16.8%. Hypertension and retinopathy were present in 36.8% and 37% of the patients respectively. A significant correlation was found between the presence of hypertension, duration of diabetes and development of diabetic nephropathy. Similarly, a significant correlation was found between retinopathy and the degree of proteinuria. In conclusion, the pattern of diabetic nephropathy in the Saudi NIDDM patients is similar to that in the Western world. Hypertension and duration of diabetes mellitus are important risk factors in the development of diabetic nephropathy. There is a good correlation between retinopathy and the degree of proteinuria.

Non-peritonitis complications of continuous ambulatory peritoneal dialysis in Saudi Arabia.

Although peritonitis is the major complication and leading cause of morbidity in patients undergoing continuous ambulatory peritoneal dialysis (CAPD), there are other complications of this long-term renal replacement therapy (RRT) modality. In order to evaluate the non-peritonitis complications, we retrospectively studied 60 new patients who were accepted in our CAPD program over a period of eight years from 1984 to 1993. Out of the 60 patients, 31 were females and 29 were males, with a mean age of 37.0 +/- 18 years. Tenckhoff's catheter was implanted by surgeons under direct vision in the operating theater through a midline incision. Nine of our patients had previous abdominal surgery and 11 females had pregnancies before CAPD, ranging from one to 10 with a mean of four. A total of 49 episodes of complications were observed, 32 early and 17 late. Early complications were defined if they occurred within three months from starting the procedure and late complications were defined as occurring after this period. There were 15 catheter blocks (25%), nine dialysate leaks (15%) and five hemoperitoneums (8.3%). Two serious and unusual complications were observed. In one of our patients, a mesenteric blood vessel injury occurred during catheter insertion, which necessitated massive blood transfusions and laparotomy. The other patient developed intestinal obstruction due to obstruction of intestinal loops around the catheter; this was corrected by removal of the catheter without the need for laparotomy. The late complications included six hernias, three hydroceles, three exit site infections, three tunnel infections and one case of loss of ultrafiltration.

Cyclosporine microemulsion formulation (sigmasporin microral) effect as first-line immunosuppressant on renal functions at 3 years.

BACKGROUND: Cyclosporine (CsA) remains a mainstay of immunosuppressive maintenance regimens in developing countries, but its effects on long-term kidney allograft survival are still unclear. Our aim was to assess a generic microemulsion CsA (Sigmasporin) for long-term impact on graft function and patient survival among stable renal transplant patients. METHODS: Over a 36-month period, patients with transplantations from >6 months earlier were maintained on CsA doses of 2-8 mg/kg/d to keep C(2) within the recommended therapeutic range. We assessed 25 efficacy and tolerability parameters of scheduled intervals. RESULTS: Twenty-seven patients (9 female, 18 male) from 6 centers in 4 Middle-Eastern countries were enrolled between 2004 and 2009. Their average age was 35.1 ± 9.8 years, body mass index ranged from 15.7 to 41.2 kg/m(2), and average time from transplantation was 2.2 ± 1.6 years. Within the 36-month observation period the CsA dose was reduced by 17.3% from 2.89 ± 0.88 mg/kg/d to achieve C(2) levels of 600-1000 ng/mL. After 36 months the glomerular filtration rate declined by 8.2% from an overall baseline mean of 72.7 ± 23.5 mL/min/1.73 m(2). It improved in 11.1% of patients and remained unchanged in 44.4%. No new cases of hypertension or diabetes mellitus were reported, and there was 1 case of borderline hyperlipidemia. Graft functions were stable, apart from 2 incidences of CsA nephrotoxicity. Both graft and patient 3-year survival rates were 100%. CONCLUSIONS: On a 3-year basis, Sigmasporin Microral was effective to maintain stable renal functions in kidney transplant patients, with safety and tolerability profiles similar to those reported in the international literature.

Successful kidney transplantation does not reverse the coagulopathy in patients with chronic renal failure on either hemo or peritoneal dialysis.

There is wide disagreement about the measurement of various hemostatic parameters in patients with chronic renal failure (CRF) concerning treatment with either hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD). This study aims to characterize the coagulopathy in patients with CRF both before initiating dialysis, when the patients are expected to have a steady hemostatic state and after starting regular HD or CAPD. The measurements were repeated in a group of patients who received a successful renal transplant to see whether the coagulopathy associated with CRF would be corrected by this lasting therapy. The study, which was mainly cross-sectional and prospective, included two groups: 49 patients with CRF with their age ranging from 17 to 67 years were divided as follows: those on regular HD (n=20), CAPD (n=9) and patients after transplant (n=20). The tests were also done on 34 healthy controls. Significant hyper-fibrinogenemia was recorded in all three study groups. The HD group showed significant elevation in the plasma levels of AT III and total protein S and a significant reduction in free protein S and protein C, when compared with healthy controls. These inhibitors, except total PS, displayed similar fluctuations in the CAPD group. In the transplant patients, there was significant elevation of AT III and total protein S, a reduction in free PS and no significant changes in PC levels. A significant elevation was found in the levels of F1+2, TAT and D-Dimer in HD and in transplant patients, when compared with controls. In CAPD patients, only D-Dimer levels showed a significant increase. The tPA and PAI-1 levels in the three study groups were similar to the control group. Our study revealed significant activation of the hemostatic system, more pronounced in patients on HD than CAPD. This coagulopathy remained only partly corrected following successful kidney transplantation.

Platelet surface receptor activation in patients with chronic renal failure on hemodialysis, peritoneal dialysis and those with successful kidney transplantation.

Hemostatic disorders associated with chronic renal failure (CRF) include hemorrhagic and/or thrombotic manifestations, which were ascribed, in part, to uremic platelet dysfunction including abnormalities of expression of platelet glycoprotein receptors. There is, however, still no general agreement on the exact characterization of these platelet abnormalities. This study aims at characterizing the platelet glycoprotein abnormalities associated with CRF, by recording the effect of the three renal replacement therapies, hemodialysis (HD), chronic ambulatory peritoneal dialysis (CAPD), and renal transplantation, on these receptors. The study, which was mainly cross-sectional, included two groups: (i) Patient groups (n = 50): HD patients (n = 20), CAPD patients (n = 10) and successful renal transplant patients (n = 20); (ii) Healthy Controls (n = 34): 23 were men and 11 were women who were age- and sex-matched with the patients. Flow cytometric quantitation of CD41, CD42a, CD42b and CD61 was carried out using a Becton-Dickinson FACScan. The expression of CD41 levels showed a highly significant increase in HD and CAPD patients when compared with the normal control levels. However, levels in transplant patients were comparable to the normal control levels. On the other hand, the expression of CD42a, CD42b, and CD61 showed no significant change in HD and CAPD patients when compared with normal control levels, but there was a significant decrease in transplant patients when compared to the normal control levels. In conclusion, there was evidence of increased expression of one glycoprotein receptor (GpIIb-IIIa) pre-dialysis whether HD or CAPD. In transplant patients, no evidence of platelet activation could be demonstrated.

Post-dialysis Solutes Rebound: Comparison of Two Protocols for Hemodialysis.

The blood urea concentration is artificially low immediately following high-efficiency dialysis. Post-dialysis urea rebound correlates with hemodialysis efficiency, and is inversely correlated with dialysis treatment time. We evaluated the effect of variation in the length of hemodialysis treatment on urea, creatinine and other solutes rebound. We used two protocols for hemodialysis, using 500-ml dialysate/min and similar dialyzed blood volume. Protocol A: hemodialysis with blood flow of 300 ml/min for four hours; protocol B: hemodialysis with blood flow of 400 ml/min for three hours. Fifteen stable anuric patients with end- stage renal disease (ESRD) were hemodialysed using each protocol, three sessions a week, for a period of two weeks. The mean dialyzed blood volume in protocol A and B was 66 +/- 4 and 67 +/- 4.8 liters/session, respectively. The mean blood flow in protocol A was 286 +/- 22 ml/min, and in protocol B was 395.3 +/- 13 ml/min. The mean urea pre and immediately post dialysis in patient using protocol A was 20.5 +/- 5.4 and 5.55 +/- 2.2 mmol/L, respectively. While in protocol B it was 19.8 +/- 4.6 and 6 +/- 1.68 mmol/L. The mean urea, one hour post dialysis, in protocol A was 6.51 +/- 1.9 Vs 8.04 +/- 2.6 mmol/L in protocol B (P value < 0.003). The percent rebound of mean blood urea concentration in protocol A and B one hour post dialysis was 17.3% vs 34%, respectively. Predialysis creatinine in protocol A and B was 894 +/- 156.8 vs 907.9 +/- 163 umol/L, respectively (P= 0.4). The immediately post-dialysis creatinine in protocol A and B, was 317+/- 98.4 vs 331 +/- 72.0 micromol/L (P = 0.4), while one hour later it was 398.6 +/- 104.0 vs 442.6 +/- 107.2 micromol/L, respectively (P value < 0.007). The percent rebound of creatinine was 25.6% in protocol A vs 33.5% in protocol B. These results show significant difference between the two protocols, and confirm increased rebound of urea and creatinine one hour post dialysis with shorter time of dialysis treatment.

Liver disease in dialysis patients with antibodies to hepatitis C virus.

Eighty-three patients with chronic end-stage renal failure, including 65 on haemodialysis and 18 on intermittent peritoneal dialysis, were evaluated for hepatitis B virus profile and antibodies to hepatitis C virus (HCV). All those positive for HBsAg were excluded from the study. Nineteen patients were found to be positive for antibodies to HCV by the ELISA II test. Eight cases were already positive for HCV antibody when they started dialysis in our unit, the other 11 became positive during dialysis in our unit. Only one of the patients on peritoneal dialysis was positive for HCV. A liver biopsy was obtained from 17 patients, who consented to the procedure. All the cases were evaluated for the number of blood transfusions received, HIV infection and the approximate time of contracting the HCV infection. Liver enzymes were determined every month. Only three patients had abnormally raised serum aminotransferase at the time of biopsy. The various histopathological lesions detected were chronic active hepatitis (n = 3, including one with changes consistent with cirrhosis), chronic persistent hepatitis (n = 4), non-specific hepatitis (n = 3) and haemosiderosis (n = 3); four biopsy samples were normal. There was no correlation between the biochemical and histopathological changes. Moreover, patients with normal serum aminotransferase levels had abnormal histopathological changes. All were negative for HIV and none of the patients had received a renal graft. Twelve patients had received blood transfusions varying from 2 to 12 units, four had not received any blood, and in one the history of blood transfusion could not be confirmed. The four patients with anti-HCV antibodies who had not received blood transfusion had relatively mild disease--non-specific hepatitis (n = 2) or normal biopsy (n = 2). One patient with cirrhosis died 30 months after liver biopsy from hepatic insufficiency and three received renal transplants. Others are continuing on dialysis and their biochemical tests are within normal limits 12-45 (30 +/- 14) months after biopsy. In conclusion, biochemical tests are poor indicators of liver disease, and liver biopsy is a definitive way of evaluating the patients of dialysis with positive HCV antibodies for prognosis.

Effect of recombinant human erythropoietin on lymphocyte phenotyping and phagocyte activity in hemodialysis patients.

The effect of recombinant human erythropoietin (rHmEPO) on lymphocytic phenotyping as well as on the phagocyte activity of polymorphonuclear cells and monocytes was evaluated in 16 patients on maintenance hemodialysis. The mean age of the patients was 38.2 +/- 16.2 years. There were seven men and nine women. All patients were started on 50 U/kg of rHmEPO intravenously three times per week, and the dosage was increased gradually to achieve target haemoglobin of 12 g/dL. Predialysis blood samples were taken monthly for 3 months, and phagocyte respiratory burst as well as lymphocyte subsets were studied. Healthy blood donors were taken as controls. By 3 months of rHmEPO treatment, there was no significant increase in total T and B cells, but there was a significant increase in both CD4 (P < 0.001) and CD8 (P < 0.005): however, there was no significant change in the CD4/CD8 ratio. There was significant reduction in the natural killer cells (P < 0.005). The phagocyte activity studies showed a significant increase in the respiratory burst in whole blood (P < 0.001) and opsonized zymosan (P < 0.001) as well as improvement in the suppressed polymorphonuclear cell and monocyte activity by uremia. Phagocytosis studied by yeast uptake showed significant improvement from the pretreatment suppressed phagocytes to normal activity posttreatment. In conclusion, treatment with rHmEPO increases CD4 and CD8 cell counts without affecting the CD4/CD8 ratio, decreases the natural killer cells, and improves the impaired phagocyte activity in hemodialysis patients.

Erythropoietin therapy in a pregnant woman on maintenance hemodialysis.

A 25 year old Saudi female, sixth gravida, para four, on renal replacement therapy with regular dialysis for nearly two years, was diagnosed to be pregnant at 12 weeks, with a single viable fetus. She was managed with increased frequency of dialysis and increased doses of anti-hypertensive drugs. For the control of anemia, which was further worsened by the pregnancy, she was treated with r-HuEPO 125 to 150 u/kg 3 times/week along with iron and vitamin supplements to maintain hemoglobin of 90 gm/L. The pregnancy continued to 36 weeks and she had a spontaneous normal delivery of a male baby without any congenital defects, weighing 1605 grams with Apgar score of four at one minute and nine at five minutes.

One-year experience of very low doses of subcutaneous erythropoietin in continuous ambulatory peritoneal dialysis and its effect on haemostasis.

Recombinant human erythropoietin (rHuEpo) is now well established in the management of the anaemia associated with chronic renal failure. The aim of this study was to assess the efficacy and safety of low doses of subcutaneous (s.c.) erythropoietin in continuous ambulatory peritoneal dialysis (CAPD) patients and particularly its effects on haemostasis. Seven CAPD patients were given s.c. erythropoietin for more than 1 year. Their mean age was 36.2 +/- 9.2 years and their mean pretreatment haemoglobin (Hb) was 7.05 +/- 0.53 g/dl. All patients were started on 20 U/kg, 3 times/week, to be doubled every 4 weeks if no response was obtained. Five patients had a good response and attained the target Hb of 10-12 g/dl and were maintained on low doses of rHuEpo (20 U/kg s.c., twice a week). A marked improvement in haemostatic function was noted when comparing the pre- with the post-treatment measurements. There was a significant reduction in the bleeding time, significant increases in fibrinogen and factor VIII clotting activity but not in von Willebrand factor antigen or ristocetin cofactor. There was also simultaneous enhancement of the platelet aggregation responses to adrenalin, collagen, arachidonic acid and ADP. In conclusion, long-term treatment with small doses of s.c. rHuEpo is safe, convenient and effective in correcting anaemia in patients on CAPD, rHuEpo caused significant improvement of bleeding time which can be explained partly through the correction of anaemia and in part by the improvement in haemostatic function.