Characteristics of all RCTs with active vitamin D analogs that had proteinuria as outcome (qualitative analysis)
Authors (yr) | Study Arms (n) | Baseline Parameters | Underlying Conditions | Follow-Up | Main Result | ||||
---|---|---|---|---|---|---|---|---|---|
ACR (mg/g) | PCR (g/g) | eGFR (ml/min per 1.73 m2) | Diabetes Mellitus (%) | ACE/ARB Use (%) | |||||
Agarwal et al.26 (2005) | Paricalcitol (57) | N/A | 24 (8) | 59 | 68 | Diverse | ≤24 wk | Dipstick proteinuria decreased in 51% of patients in paricalcitol group and 25% of patients in placebo group (P=0.004) | |
Placebo (61) | 23 (7) | 58 | 70 | ||||||
Alborzi et al.27 (2008) | Paricalcitol 1 μg/d (8) | 72 (30–172) | 48 (9) | 50 | 100 | Diverse | 1 mo | From baseline to last measurement, ACR increased in placebo group but decreased in both paricalcitol groups | |
Paricalcitol 2 μg/d (8) | 39 (18–82) | 47 (13) | 88 | 100 | |||||
Placebo (8) | 241 (57–1022) | 44 (12) | 75 | 100 | |||||
Fishbane et al.30 (2009) | Paricalcitol 1 μg/d (31) | 2.6 (N/A) | 40 (24) | 65 | 89 | Diverse | 6 mo | PCR placebo: +2.9%; paricalcitol: −17.6%, P=0.04 | |
Placebo (30) | 2.8 (N/A) | 35 (18) | 50 | 93 | |||||
de Zeeuw et al.29 (2010) | Paricalcitol 1 μg/d (93) | 894 (832) | 40 (15) | 100 | 100 | Diabetic nephropathy | 24 wk | ACR from baseline to last evaluation was −3% in placebo group, −14% in 1 μg paricalcitol group, and −20% in 2 μg paricalcitol group (P=0.05) | |
Paricalcitol 2 μg/d (95) | 814 (761) | 42 (18) | 100 | 100 | |||||
Placebo (93) | 832 (717) | 39 (17) | 100 | 100 | |||||
De Boer et al.32 (2013)a | Paricalcitol 2 μg/d (11) | 593 (1460) | 39 (12) | 0 | 73 | Diverse | 8 wk | ACR at last evaluation was 15% lower after paricalcitol than after placebo treatment when comparing individual patients (P=0.31) | |
Placebo (11) | 257 (478) | 40 (12) | 0 | 91 | |||||
Thadhani et al.33 (2012)b | Paricalcitol 2 μg/d (62) | 450 (156–1040) | 30 (24–36) | 58 | 84 | Diverse | 48 wk | Adjusted mean change in log-transformed ACR at week 48 was −0.11 [95% CI, −0.35 to 0.13] in paricalcitol group and 0.10 [95% CI, −0.14 to 0.33] in placebo group (P=0.23) | |
Placebo (59) | 278 (88–980) | 31 (23–39) | 56 | 80 | |||||
Liu et al.31 (2012) | Calcitriol 0.5 μg 2×/wk (25) | N/Ac | 83 (36) | 0 | 100 | IgA nephropathy | 48 wk | 24 h proteinuria from baseline to last evaluation was +21% in control group and −19% in calcitriol group (P=0.03) | |
No treatment (25) | 78 (28) | 0 | 100 | ||||||
Krairittichai et al.28 (2012) | Calcitriol 0.5 μg 2×/wk (46) | 3.73 (2.20) | 38 (18) | 100 | 61 | Diabetic nephropathy | 16 wk | Urinary PCR decreased by 18.7% in calcitriol group and increased by 9.9% in control group (P<0.01) | |
No treatment (45) | 3.39 (2.10) | 37 (17) | 100 | 53 |
ACR, protein to creatinine ratio (PCR), and eGFR data presented as mean (SD) or median (95% CI) depending on their distribution. N/A, not available.
↵a The original study had a crossover design. To avoid repeated inclusion, we used data from the first study period only.
↵b Data represent the subgroup of patients with albuminuria at baseline. Baseline data for the complete study population are available in the original publication.33
↵c No baseline PCR/ACR data were available. The 24-hour urinary protein excretion at baseline was 1.60 g/24 h in the calcitriol-treated group and 1.29 g/24 h in the control group.