[Kt calculation as a quality indicator of haemodialysis adequacy]. / Cálculo del Kt como indicador de calidad en el área de adecuación en hemodiálisis.

The haemodialysis dose is a good marker of dialysis adequacy, and we usually monitor it with Kt/V measure. The dialysis dose monitored with Kt allows a better discrimination, detecting a percentage of the patients that perhaps do not get an adequate dose for their gender or body surface area after treatment with a minimum recommended dose of Kt/V. The objective of this study was to evaluate Kt as a clinical indicator referred to dialysis adequacy in the haemodialysis population. The aim was that more than 85% of the patients would achieve the recommended Kt target for their gender (at least 50 litres in men and 45 litres in women), or their body surface area. In each of the patients (mean 129) the Kt mean value was determined for three consecutive dialysis sessions, one every two months, during the follow-up period (14 months). At the beginning, the Kt/V value was on target (> 1.3) in 93.2% of the patients, but only in 58% according to Kt measure for their gender. After 4 months, we observed that 85% of patients' Kt target increased for their gender, but only 68% did if we used the Kt individualised for their body surface area. From month 6 to the end of the follow-up period, more than 85% of patients obtained an adequate Kt for their body surface area (p < 0.001). A significant increase of Kt mean (5.4 litres) was observed at the end of the study (p < 0.001). The usual dialysis prescription parameters were modified increasing blood flow rate (34.14 ml/min, p < 0.001), session effective duration (8.04 minutes, p < 0.001), dialyser surface area (24.1% of patients changed from helixone 1.3 to 1.6 m2, p < 0.001) and haemodialysis modality (56.8% of patients changed from conventional haemodialysis to on-line haemodiafiltration, p < 0.001). We conclude that monitoring dialysis dose with Kt is a good clinical measure of adequacy, and using it as a quality indicator can be done in line with the more demanding quality standards.

[Importance of ultrapure dialysis liquid in response to the treatment of renal anaemia with darbepoetin in patients receiving haemodialysis]. / Importancia del líquido de diálisis ultrapuro en la respuesta al tratamiento de la anemia renal con darbepoetina en el paciente en hemodiálisis.

Chronic inflammatory diseases and infections are a major cause of hyporesponse to erythropoiesis-stimulating factors. We conducted this prospective study in 107 patients in haemodialysis with dialysis liquid that was potentially contaminated from a bacteriological perspective in order to test the hypothesis that ultrapure dialysis liquid can improve the response to treatment with darbepoetin and reduce inflammatory markers. These patients had to have been stable in the last 8 weeks in relation to haemoglobin level and the administered dose of darbepoetin. Two filters (one of hydrophilic nylon and another of polysulfone) were added to the water treatment process, the first one prior to distribution ring output and the second before the dialyser. The patients were evaluated for 12 months. The dosage of darbepoetin was varied to maintain haemoglobin levels ranging from 11 to 14 g/dl. We measured resistance to the erythropoiesis-stimulating factor, defined as the quotient between weekly dose of darbepoetin and haemoglobin levels, baseline and every two months, the baseline and monthly endotoxin count and reactive protein C at baseline and every 6 months. 94 patients completed the study. The resistance index fell significantly during follow-up (p<0.001) and was measurable from the second month on. Haemoglobin levels remained within the established margins with a 34% reduction in the weekly dose of darbepoetin at the end of the follow-up period. Both reactive protein C and the endotoxin count were significantly reduced (p<0.001) compared to baseline after 6 and 12 months. To conclude, the bacteriological purity of the dialysis liquid reduces inflammatory markers in patients receiving haemodialysis, improving the response to treatment with darbepoetin in renal anaemia.

Efecto de irbesartán en patología renal proteinúrica no diabética / Effect of irbesartan in proteinuric non-diabetic renal disease

Este estudio clínico aleatorizado, prospectivo, de dos brazos, evaluó el efecto antiproteinúricoy nefroprotector, así como la seguridad del tratamiento con un antagonistade los receptores de angiotensina II (irbesartán) en pacientes con glomerulonefritiscrónica (GNC), comparándolo con inhibidores del enzima convertidor deangiotensina (IECA). Un total de 50 pacientes con GNC diagnosticada mediantebiopsia renal y proteinuria en orina de 24 horas mayor a 1 g fueron incluidos. Todosellos recibieron tratamiento durante al menos 24 meses, 27 en el grupo 1 (irbesartán)y 23 en el grupo 2 (IECA). En los dos grupos encontramos una reducción significativa(p < 0,001) de la proteinuria (49,2% en el grupo 1 y 44,8% en el grupo 2)desde el tercer mes, que se confirma a los 12 y 24 meses de seguimiento (58,1% y62,7% en el grupo 1, y 56,8% y 55,4% en el grupo 2, respectivamente), aunque nose observaron diferencias significativas entre los dos grupos. No encontramos diferenciasrespecto al control tensional. En ninguno de los dos grupos encontramos undescenso significativo del filtrado glomerular, sin embargo, éste fue mayor en elgrupo tratado con EICA (2,98 ± 7,77 vs 1,64 ± 6,84 ml/min/año) aunque sin diferenciasignificativa respecto a irbesartán, mientras que tres pacientes inicialmentetratados con IECA mostraron intolerancia (tos). Como conclusión, en nuestro estudioirbesartán mostró un efecto antiproteinúrico y nefroprotector similar a los IECAen pacientes con glomerulonefritis crónica, siendo además segura su administración

This randomized, prospective, two-arm clinical study evaluated the antiproteinuricand nephroprotective effects and the safety of treatment with an angiotensin II receptorantagonist (irbesartan) in patients with cronic glomerulonephritis (CGN) ascompared to angiotensin-converting enzyme inhibitors (ACEIs). A total of 50 patientswith CGN diagnosed by renal biopsy and protein levels in 24-hour urine higherthan 1 g were enrolled. All patients received treatment for at least 24 months, 27 in group 1 (irbesartan) and 23 in group 2 (ACEs). A significant decrease in proteinuria(p < 0.001) was seen in both groups (49.2% in group, 1, and 44.8% in group 2)since the third month, and confirmed at 12 and 24 months of follow-up (58.1% and62.7% in group 1, and 56.8% and 55.4% in group 2, respectively), with no significantdifferences being seen between the two groups. No differences were found inblood pressure control. No significant decrease was found in any of the groups inthe glomerular filtration rate, but this showed higher values in the group treated withACEIs (2.98 ± 7.77 vs 1.64 ± 6.84 ml/min/year), though the difference with irbersartanwas not statistically significant. No side effects occurred among patients treatedwith irbesartan, whereas three patients initially treated with ACEIs showed intolerance(cough). In conclusion, irbesartan showed in our study an antiproteinuric andnephroprotective effect similar to ACEIs in patients with chronic glomerulonephritis,and its administration was also shown to be safe

[Effect of irbesartan in proteinuric non-diabetic renal disease]. / Efecto de irbesartin en patología renal proteinúrica no diabética.

This randomized, prospective, two-arm clinical study evaluated the antiproteinuric and nephroprotective effects and the safety of treatment with an angiotensin II receptor antagonist (irbesartan) in patients with chronic glomerulonephritis (CGN) as compared to angiotensin-converting enzyme inhibitors (ACEIls). A total of 50 patients with CGN diagnosed by renal biopsy and protein levels in 24-hour urine higher than 1 g were enrolled. All patients received treatment for at least 24 months, 27 in group 1 (irbesartan) and 23 in group 2 (ACEs). A significant decrease in proteinuria (p < 0.001) was seen in both groups (49.2% in group, 1, and 44.8% in group 2) since the third month, and confirmed at 12 and 24 months of follow-up (58.1% and 62.7% in group 1, and 56.8% and 55.4% in group 2, respectively), with no significant differences being seen between the two groups. No differences were found in blood pressure control. No significant decrease was found in any of the groups in the glomerular filtration rate, but this showed higher values in the group treated with ACEIs (2.98 +/- 7.77 vs 1.64 +/- 6.84 ml/min/year), though the difference with irbersartan was not statistically significant. No side effects occurred among patients treated with irbesartan, whereas three patients initially treated with ACEIs showed intolerance (cough). In conclusion, irbesartan showed in our study an antiproteinuric and nephroprotective effect similar to ACEIs in patients with chronic glomerulonephritis, and its administration was also shown to be safe.

[Treatment of renal anemia with darbepoetin alfa administered once every other week in predialysis patients with chronic kidney disease and previously treated with epoetin alfa]. / Tratamiento de la anemia renal con administración una vez cada dos semanas de darbepoetina alfa en pacientes con insuficiencia renal crónica prediálisis previamente tratados con epoetina alfa.

Darbepoetin alfa is an erythropoiesis-stimulating glycoprotein with up to 3 times longer half-life than recombinant human erythropoietin (rHuEPO) in humans. The aim of this study was to assess the efficacy and safety of darbepoetin alfa given once every other week as treatment of anemia in predialysis patients with chronic renal failure (CRF) previously treated with once-weekly epoetin alfa. A total of 42 CRF patients were included, all of whom had previously been treated with epoetin alfa and showed stable hemoglobin (Hb) levels without dose changes during the last 8 weeks prior to enrolment in this study. All patients received s.c. darbepoetin alfa once every other week at doses calculated from the protein mass equivalence between rHuEPO and darbepoetin alfa. Follow-up lasted for 24 weeks. Dose adjustments were conducted to preserve target Hb levels between 11 and 13 g/dl. Thirty-nine patients completed the 24 weeks of study. Hb levels increased during follow-up [mean values of 0.39 (p < 0.002), 0.58) (p < 0.001), and 0.83 g/dl (p < 0.001) at 8, 16 and 24 weeks, respectively] despite reducing the darbepoetin alfa dose up to 15% at 24 weeks [from 0.192 microg/kg body weight to 0.185, 0.178 and 0.163 at 8, 16, and 24 weeks, respectively (p < 0.001)]. No adverse events related to darbepoetin alfa were reported. In conclusion, these results show s.c. administration of darbepoetin alfa once every other week was superior to weekly epoetin alfa as a maintenance treatment for anemia in predialysis CRF patients, since the former provided higher Hb levels. Moreover, darbepoetin alfa administration was safe in these patients.

[Change of EPO treatment from subcutaneous epoetin to intravenous epoetin or darbepoetin alpha]. / Estudio comparativo sobre el tratamiento de la anemia renal en el paciente en hemodiálisis: cambio de vía de administración de epoetina alfa frente a conversión a darbepoetina.

This prospective, two-arm, clinical trial assesses the effectiveness in maintaining the levels of haemoglobin (Hb) between 11 and 13 g/d1 and the safety of changing the administration route (from subcutaneous to intravenous) of epoetin (rHuEPO) alpha at equidose versus a changeover to darbepoetin alpha, taking the exact equivalence in peptide mass between the two as referent in patients with chronic renal insufficiency (CRI) in haemodialysis. A total of 112 patients previously treated with epoetin and no dose modification during the 8 weeks prior to the study and stable levels of Hb were included. Of these, 92.1% finished the follow-up period (24 weeks). After changing the administration route of rHuEPO, a significant increase in the resistance index (REI, weekly dose per kilogram of weight/levels of hemoglobin) was observed with mean values of 2.73 (p < 0.018) and 4.37 (p < 0.001) after 16 and 24 weeks respectively, requiring an increase of the dose greater than 15% over the baseline in 6 1.1% of the patients. The changeover to, darbepoetin alpha, independently of the administration route, was accompanied by a decrease in REI starting in the 8th week (mean levels of 0.012, 0.018 and 0.023 after 8, 16 and 24 weeks respectively), significant (p < 0.001) at the 3 cutoff points of the study. The conversion factor increased significantly up to 1:260 in week 24. Both erythropoietic stimulating factors (EST) were well tolerated and no unexpected side effects were observed. In conclusion, treatment of anaemia with darbepoetin alpha in patients with CRI in haemodialysis previously treated with rHuEPO proved to be more effective than the use of epoetin intravenously, significantly improving the resistance index. In addition, the treatment with darbepoetin alpha was well tolerated in these patients.