Efficacy and safety of calcitriol therapy for reduction of proteinuria in children with chronic kidney disease: an open-label randomized controlled trial.

PURPOSE: Reducing proteinuria in children with chronic kidney disease (CKD) has been shown to slow the progression of kidney damage. Hence, we examined the efficacy of a combination of calcitriol and enalapril as compared to enalapril alone in reducing proteinuria in children with CKD.

METHODS

Children aged 3 to 18 years with CKD and proteinuria > 250 mg/m2/day were randomized to receive enalapril (0.6 mg/kg/daily) with or without calcitriol (0.25 µg twice weekly) for 6 months. Children with estimated GFR (eGFR) < 30 ml/min/1.73 m2, serum calcium > 10.5 mg/dl, and phosphate > 5.5 mg/dl were excluded. A primary outcome was a mean difference in the change in proteinuria at 6 months compared to baseline. Secondary outcomes included changes in PTH and eGFR.

RESULTS

Of 212 screened children with CKD and proteinuria, 72 (56 boys, mean age 11.2 ± 3.4 yr) were randomized. Baseline characteristics were similar in both groups. Proteinuria decreased from the baseline to the end of therapy by median 1.05 (IQR: 0.04 to 1.87) g/day with the combination therapy as compared to median 0.49 (IQR: 0.03 to 1.33) g/day in enalapril group (P = 0.54). The percentage reduction in proteinuria was 60.4% with the combination therapy and 50.1% with enalapril therapy (P = 0.48). Three patients developed hyperphosphatemia in enalapril therapy; hypercalcemia and hyperkalemia were not observed.

CONCLUSION

In children with CKD, the combination of calcitriol and enalapril did not result in significant reduction in proteinuria than enalapril alone. Combination therapy was tolerated well. Further studies with a larger sample size and a longer duration of follow-up studies are needed. Trial registration https://ctri.nic.in CTRI/2011/10/002086. Registered in October 21, 2011.