BACKGROUND:Vitamin D has shown efficacy in the reduction of proteinuria in patients with chronic kidney disease. This study aimed to determine the effect of calcitriol on urinary protein excretion in patients with immunoglobulin A (IgA) nephropathy. STUDY DESIGN: Open-label, non-placebo-controlled, randomized study. SETTING & PARTICIPANTS: 50 patients with IgA nephropathy were enrolled. The main criterion for inclusion was urinary protein excretion >0.8 g/d after renin-angiotensin system-inhibitor treatment for at least 3 months. INTERVENTION: Patients were randomly assigned (1:1) to receive 2 doses (0.5 μg) of calcitriol per week or no treatment for 48 weeks. OUTCOMES: The primary end point was to compare change in 24-hour urinary protein excretion from baseline to last measurement during treatment. MEASUREMENTS: Every 8 weeks, there was measurement of 24-hour urinary protein excretion, serum calcium, serum phosphorus, serum creatinine, and intact parathyroid hormone. RESULTS: Measurement of the primary end point showed changes in urinary protein excretion of +21% (from 1.29 to 1.58 g/24 h; 95% CI, -9% to +52%) in the control group and -19% (from 1.60 to 1.30 g/24 h; 95% CI, -42% to +4%) in the calcitriol-treated group. There was a significant decrease in proteinuria in the calcitriol-treated group compared with the control group (difference between groups, 41%; 95% CI, 5%-79%; P = 0.03). The secondary end point of achieving at least a 15% decrease in proteinuria was attained by 7 of 24 (29%) controls and 17 of 26 (65%) of those treated with calcitriol (P = 0.02). No significant differences were observed in decrease in estimated glomerular filtration rate and change in blood pressure between the 2 groups. The incidence of recorded adverse events was similar between the 2 groups. LIMITATIONS: Small and non-placebo-controlled study. CONCLUSIONS: The addition of calcitriol to a renin-angiotensin system inhibitor resulted in a safe decrease in proteinuria in patients with IgA nephropathy.
RCT Entities:
BACKGROUND:Vitamin D has shown efficacy in the reduction of proteinuria in patients with chronic kidney disease. This study aimed to determine the effect of calcitriol on urinary protein excretion in patients with immunoglobulin A (IgA) nephropathy. STUDY DESIGN: Open-label, non-placebo-controlled, randomized study. SETTING & PARTICIPANTS: 50 patients with IgA nephropathy were enrolled. The main criterion for inclusion was urinary protein excretion >0.8 g/d after renin-angiotensin system-inhibitor treatment for at least 3 months. INTERVENTION: Patients were randomly assigned (1:1) to receive 2 doses (0.5 μg) of calcitriol per week or no treatment for 48 weeks. OUTCOMES: The primary end point was to compare change in 24-hour urinary protein excretion from baseline to last measurement during treatment. MEASUREMENTS: Every 8 weeks, there was measurement of 24-hour urinary protein excretion, serum calcium, serum phosphorus, serum creatinine, and intact parathyroid hormone. RESULTS: Measurement of the primary end point showed changes in urinary protein excretion of +21% (from 1.29 to 1.58 g/24 h; 95% CI, -9% to +52%) in the control group and -19% (from 1.60 to 1.30 g/24 h; 95% CI, -42% to +4%) in the calcitriol-treated group. There was a significant decrease in proteinuria in the calcitriol-treated group compared with the control group (difference between groups, 41%; 95% CI, 5%-79%; P = 0.03). The secondary end point of achieving at least a 15% decrease in proteinuria was attained by 7 of 24 (29%) controls and 17 of 26 (65%) of those treated with calcitriol (P = 0.02). No significant differences were observed in decrease in estimated glomerular filtration rate and change in blood pressure between the 2 groups. The incidence of recorded adverse events was similar between the 2 groups. LIMITATIONS: Small and non-placebo-controlled study. CONCLUSIONS: The addition of calcitriol to a renin-angiotensin system inhibitor resulted in a safe decrease in proteinuria in patients with IgA nephropathy.
Authors: Sandra Rayego-Mateos; Jose Luis Morgado-Pascual; José Manuel Valdivielso; Ana Belén Sanz; Enrique Bosch-Panadero; Raúl R Rodrigues-Díez; Jesús Egido; Alberto Ortiz; Emilio González-Parra; Marta Ruiz-Ortega Journal: J Am Soc Nephrol Date: 2020-07-06 Impact factor: 10.121
Authors: Luigi Francesco Morrone; Pergiorgio Bolasco; Corrado Camerini; Giuseppe Cianciolo; Adamasco Cupisti; Andrea Galassi; Sandro Mazzaferro; Domenico Russo; Luigi Russo; Mario Cozzolino Journal: J Nephrol Date: 2016-04-09 Impact factor: 3.902
Authors: Martin H de Borst; Reza Hajhosseiny; Hector Tamez; Julia Wenger; Ravi Thadhani; David J A Goldsmith Journal: J Am Soc Nephrol Date: 2013-08-08 Impact factor: 10.121