Use of Basiliximab with the Standard Immunosuppressive Protocol in Pediatric Renal Transplantation: A Double-Blind Randomized Clinical Trial.

BACKGROUND: Several randomized clinical trials performed on adult renal transplant recipients have shown a significant reduction in the incidence of acute rejection by using basiliximab as induction therapy. However, few studies have been conducted on kidney graft survival following the use of the drug among pediatric transplant recipients. OBJECTIVE: To address the efficacy and safety of basiliximab in the improvement of the survival of children with kidney transplants. METHODS: This randomized, double-blind single-center clinical trial was conducted on 28 children (57% male) who underwent live-unrelated renal transplantation. They were randomly assigned into an intervention group receiving basiliximab (10 mg in patients weighing <40 kg or 20 mg in patients ≥40 kg) as induction therapy in combination with the standard immunosuppressive regimen (n=14), or to the control group (n=14) receiving only the standard immunosuppressive regimen (without basiliximab). The outcome was assessed by the measurement of serum creatinine level before transplantation, and 24, 48, and 72 hours as well as 3, 6, and 12 months post-transplantation. The estimated glomerular filtration rate at 12 months post-transplantation and graft survival were also measured. The number of acute rejection episodes in transplant recipients was also considered. RESULTS: The mean±SD age of participants was 12.3±4.2 years. No difference was observed between the two groups in terms of serum creatinine level before and after transplantation at various time points. The mean±SD eGFR at 12 months post-transplantation was 87.8±8.4 in the basiliximab and 85.2±5.8 in the control group (p=0.37). No significant difference was observed between the two groups in terms of acute rejection episodes (25% in basiliximab and 33% in the control group). The graft survival at 1-year post-transplantation was 93% in the basiliximab and 86% in the control group (p=0.54). CONCLUSION: Adding basiliximab to the standard immunosuppressive regimen may not improve the graft survival.

Investigation of ATP6V1B1 and ATP6V0A4 genes causing hereditary hearing loss associated with distal renal tubular acidosis in Iranian families.

BACKGROUND: Hearing defects are the most common sensory disorders, affecting 1 out of every 500 newborns. ATP6V1B mutations are associated with early sensorineural hearing loss, whereas ATP6V0A4 mutations are classically associated with either late-onset sensorineural hearing loss or normal hearing. ATP6V1B1 and ATP6V0A4 genetic mutations cause recessive forms of distal renal tubular acidosis. METHOD: Ten unrelated deaf Iranian families with distal renal tubular acidosis were referred to the Genetics Research Centre, University of Social Welfare and Rehabilitation Sciences, Tehran. All exons of the ATP6V1B1 and ATP6V0A4 genes were sequenced in affected family members. RESULTS: We identified a previously reported ATP6V1B1 frameshift mutation (P385fsX441) in two families and a nucleotide substitution in exon 10 (P346R) in three families. In addition, one patient was homozygous for a novel nucleotide substitution in exon 3. CONCLUSION: ATP6V1B1 genetic mutations were detected in more than half of the families studied. Mutations in this gene therefore seem to be the most common causative factors in hearing loss associated with distal renal tubular acidosis in these families.

Slow graft function after pediatric renal transplantation from volunteer live donors.

Slow graft function (SGF) may occur during the early post-transplant period. In this paper, we present our findings regarding SGF after pediatric renal transplantation and its predictive variables. From 1985 to 2004, a total of 300 pediatric renal transplants were performed at our institution. A total of 10 cases with SGF and 50 controls that were operated by the same surgeons were enrolled in this study. The mean age of the recipients and donors was 11.4 (3-15 yr) and 28.05 yr (20-50 yr), respectively. All kidneys were retrieved from living donors. We compared patients with SGF with controls regarding four independent variables: age difference between donors and recipients, serum hemoglobin difference between donors and recipients, mean blood pressure (systolic blood pressure + 2 [diastolic blood pressure]/3) difference between donors and recipients, and weight difference between donors and recipients. The mean age of recipients was 10.5 +/- 4.1 in SGF group and 11.6 +/- 2.5 in control group (p = 0.4). The differences between donors and recipients regarding weight and mean blood pressure in subjects with SGF were not higher than other patients (42 kg vs. 37.4 kg, p = 0.4; -3 mmHg vs. -4.1 mmHg, p = 0.8). The mean hemoglobin difference between donors and recipients was 6.3 +/- 2.1 g/dL in SGF group and 6.7 +/- 2.3 g/dL in control group (p = 0.6). The differences between donors and recipients regarding age, weight, mean blood pressure and serum hemoglobin level are not predictive variables for SGF.

Mycophenolate mofetil in pediatric renal transplantation.

INTRODUCTION: Since kidney transplantation is the therapy of choice for children with end-stage renal disease (ESRD), we investigated the effects of mycophenolate mofetil (MMF) in pediatric renal transplantation. METHODS AND SUBJECTS: Two hundred sixteen children received renal transplants between 1985 and 2003: 100 patients received MMF with cyclosporine and prednisolone (cases), and 116 patients, azathioprine with cyclosporine and prednisolone (controls). RESULTS: The MMF group (100 patients) showed better graft survival and function than the AZA group (116 patients). Patients who received MMF immediately after transplantation experienced less graft loss and acute rejection episodes in the first 3 months after transplantation (P < .05). Patients who received MMF at the time of diagnosis of chronic rejection had stable renal function and remarkably better graft survival than those with chronic rejection who received AZA instead of MMF (P < .05). CONCLUSION: This study suggests that MMF may stop persistent graft dysfunction in chronic rejection, improving graft survival in the short and long terms posttransplantation.

Outcome of renal transplantation in children with low urinary tract abnormality.

INTRODUCTION: Patients with end-stage renal disease and lower urinary tract abnormality are often considered high risk for renal transplantation. METHODS AND SUBJECTS: To examine the degree of risk, we studied patients who received renal transplants between 1985 and 2003. Forty eight patients had congenital lower urinary tract anomalies and 168 patients comprised a control group without these anomalies. RESULTS: Mean age and distribution of sex were not significantly different between the case and the control group. Among patients with anomalies, 8% had delayed graft function; 75%, acute rejection; and 39.5%, chronic rejection. Among the controls 2.3% had delayed graft function; 59%, acute rejection; and 35%, chronic rejection. None of these differences was significant. Mean survival time was 6 years in affected patients and 7.3 years in the control group (P = .7). Among patients with anomalies the rate of graft survival in the first year after transplantation was 90%; and those in the third, fifth, and seventh years, 76%, 65%, and 40%, respectively. For the controls, the graft survivals were 88% at 1 year; 73% at 3 years; 70% at 5 years; and 49% at 7 years after transplantation. CONCLUSION: This study showed that a history of lower urinary tract anomalies had no effect on graft function. Graft survival was not different among these patients compared with patients free of these anomalies.