Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study.

OBJECTIVE: We analyzed the efficacy and safety of an everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. METHODS: In this 24-month, open-label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids. RESULTS: Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2 or treated biopsy-proven acute rejection (27.0% vs. 29.2%, P = .011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m2 , P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m2 , P = .0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm. CONCLUSION: This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).

Cost of Drivers among Patients in the First Year after Kidney Transplantation - A Retrospective Study.

The cost of kidney transplantation (KT) and its follow-up care greatly exceeds the mean annual family income. Governmental support during the post-transplant period is needed. This study aimed to identify the drivers of cost during the 1st year after KT. The records of 129 adult Filipino KT recipients over 2 years in a single center were reviewed to determine the total cost for the 1st year after KT, such as diagnostics, medications, supplies, and professional fees. Univariate and multivariate analyses were carried out to determine the economic impact of the baseline characteristics, comorbidities, and events after KT. The direct costs of care were significantly higher among patients aged >40 years (P = 0.009), those with diabetic kidney disease as the primary renal disease (P <0.0001), and those with a high Charlson comorbidity index (P = 0.001). Multivariate regression analysis showed that patients with diabetes mellitus paid US$ 6813.6 more, and those hospitalized for any infection spent US$ 3877.4 more than those without comorbid conditions or complications. The results showed that diabetes mellitus and hospitalization for any infection significantly impacted the cost of follow-up care. Health-care policies that can aid patients after KT are needed to minimize expenditures and avoid complications.

Impact of Age Difference, Sex Matching, and Body Mass Index Matching Between Donor and Recipient in Renal Transplant.

BACKGROUND: Various factors influence kidney transplant (KT) outcome. The impact of age difference between donor and recipient on long- and short-term graft and patient survival in living donor KT remains unclear. OBJECTIVE: We aim to determine whether age difference, sex matching, and body mass index (BMI) matching between donor and recipient affect the 12-month patient and graft survival in KT. METHOD: We studied a retrospective cohort of 804 patients 18 years or older with primary KT from January 2010 to December 2014. Patient renal function and patient survival were followed up for 12 months post KT. Repeated analysis of variance measurement determined if there was a significant difference in the mean creatinine levels when the sample was grouped according to the matching groups for sex, age difference, and BMI classification. Odds ratios were computed to ascertain graft loss and graft rejection. Results were considered statistically significant if P < .05. RESULTS: Male donor-female recipient had the lowest creatinine levels over time compared with male donor-male recipient (P < .001) and female donor-male recipient (P < .001). Older donor-younger recipient with age difference of ≥ 15 years had the highest overall creatinine (P < .001). For BMI matching, a normal donor and an underweight recipient combination resulted in the lowest mean creatinine levels over the course of 12 months (P < .001). In terms of graft rejection, odds ratio was highest for a female donor and a male recipient (P < .00a) compared with a male donor and a female recipient. For graft loss, older donors (≥ 15 years) had the highest risk (P < .001) vs those older by 11 to 15 years. CONCLUSION: There was significant difference in the 12-month graft function of patients when grouped according to their matching for age difference, sex, and BMI. The risk for graft rejection increases when the combination for donor-recipient is female donor-male recipient. For graft loss, this is most significant for donors who are older by ≥ 15 years than their recipients.

Patient and Graft Outcomes Among Filipino Post-kidney Transplant Pregnancies.

BACKGROUND: Kidney transplantation (KT) has been shown to improve fertility rates among women post-transplant. However, despite the favorable outcome, the impact of pregnancy on the graft and the graft's effect on the fetus should be considered. In addition, these patients are exposed to anti-rejection medications that could affect the fetus. OBJECTIVE: To describe the graft and pregnancy outcomes among KT recipients. METHODOLOGY: Descriptive study of 32 post-KT recipients who were pregnant from January 1, 2001 to December 31, 2016 and were followed up 3 months post-partum. Each pregnancy was considered as an event. RESULTS: Among the 32 post-KT patients there were 38 pregnancies. Mean age at conception was 34 years, with a mean interval between KT and pregnancy of 4.8 years. Around 84% took cyclosporine-based immunosuppression. The mean pre-natal serum creatinine was 1.15 mg/dL, 5.3% had ≥ 1.5 mg/dL pre-natal creatinine, and the rejection rate was 10.5%. The results of the pregnancies were as follows: 94% resulted in live births, 18.42% of mothers had pre-eclampsia, 3% had eclampsia, 3% ended in abortion, and 3% were stillbirth. Sixty-eight percent of the pregnancies were unplanned, and more complications were observed among these patients. CONCLUSION: The maternal and fetal outcomes and complications in this study were comparable with other studies. However, most of these complications were observed with unplanned pregnancies. Counselling prior to pregnancy should therefore be emphasized.

Randomized trial of Alemtuzumab for prevention of graft rejection and preservation of renal function after kidney transplantation.

BACKGROUND: A randomized, multicenter, controlled trial was undertaken to evaluate the safety and efficacy of Alemtuzumab, a powerful lytic agent for both T and B lymphocytes, in the prophylaxis of rejection in renal transplantation (RTx). METHODS: Thirty patients were randomized to receive Alemtuzumab together with low-dose cyclosporine (CsA) monotherapy (CAMPATH, n = 20) or to full doses of CsA with azathioprine and corticosteroids (Standard, n = 10). CsA was administered at doses to achieve whole-blood trough CsA levels of 90 to 110 ng/mL and 180 to 225 ng/mL in CAMPATH and Standard groups, respectively. RESULTS: Per protocol, CsA trough levels were lower in patients assigned to CAMPATH post-RTx (median trough level of 119 vs. 166 ng/mL at 6 months, CAMPATH vs. Standard; 95% confidence interval, -92 to -34). At 6 months post-RTx, serum creatinine, graft and patient survivals, incidence of biopsy proven acute rejection (25% vs. 20%, CAMPATH vs. Standard), overall treatment failure, and severe and moderate infections were comparable. Whereas all patients receiving Standard therapy required maintenance corticosteroids at 6 months, of the 17 of 20 patients with functioning grafts in CAMPATH, 15 (88%, 95% confidence interval, 53%-97%) were steroid free. CONCLUSION: These results suggest that Alemtuzumab is an effective induction agent that permits low-dose steroid-free immunosuppression in RTx.