Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial.

Abstract

BACKGROUND:

Vitamin D has key roles in regulating systems that could be important in the pathobiological state of proteinuria. Because of this, it could be helpful in treating patients with proteinuric renal diseases. The objective is to determine the effect of oral paricalcitol on protein excretion in patients with proteinuric chronic kidney disease.

STUDY DESIGN:

Double-blind randomized study.

SETTING & PARTICIPANTS:

61 patients with estimated glomerular filtration rate of 15 to 90 mL/min/1.73 m(2) and protein excretion greater than 400 mg/24 h.

INTERVENTION:

Randomization to 6 months of treatment with paricalcitol, 1 mug/d, or placebo.

OUTCOMES & MEASUREMENTS:

The predefined primary end point was to compare change in mean spot urinary protein-creatinine ratio between the baseline measurement and the last study evaluation (6 months in study completers) between the 2 groups. Every 4 weeks, there was measurement of serum intact parathyroid hormone, serum calcium, serum phosphorus, serum creatinine, and urine spot protein and creatinine.

RESULTS:

At baseline, mean urinary protein-creatinine ratios were 2.6 and 2.8 g/g in the placebo and paricalcitol groups, respectively. At final evaluation, mean ratios were 2.7 and 2.3, respectively. Changes in protein excretion from baseline to last evaluation were +2.9% for controls and -17.6% for the paricalcitol group (P = 0.04). A 10% decrease in proteinuria occurred in controls (7 of 27; 25.9%) and the paricalcitol group (16 of 28; 57.1%; P = 0.03).

LIMITATIONS:

The relatively small sample size limits the extent to which results should be generalized.

CONCLUSIONS:

Paricalcitol resulted in a significant reduction in protein excretion in patients with proteinuric renal disease.

• Authors: Steven Fishbane, Harini Chittineni, Michal Packman, Paula Dutka, Nicole Ali, Nicole Durie
• Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation (Am J Kidney Dis) Vol. 54 Issue 4 Pg. 647-52 (Oct 2009) ISSN: 1523-6838 [Electronic] United States
• PMID: 19596163 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Bone Density Conservation Agents
• Ergocalciferols
• Parathyroid Hormone
• Phosphorus
• paricalcitol
• Creatinine
• Calcium

Topics

• Administration, Oral
• Adult
• Aged
• Biomarkers (blood)
• Bone Density Conservation Agents (administration & dosage, therapeutic use)
• Calcium (blood)
• Creatinine (blood, urine)
• Double-Blind Method
• Ergocalciferols (administration & dosage, therapeutic use)
• Female
• Glomerular Filtration Rate (drug effects)
• Humans
• Male
• Middle Aged
• Parathyroid Hormone (blood)
• Phosphorus (blood)
• Proteinuria (blood, drug therapy, etiology, physiopathology)
• Renal Insufficiency, Chronic (blood, complications, drug therapy, physiopathology)
• Sample Size
• Treatment Outcome
• Vitamin D Deficiency (blood, complications, drug therapy, physiopathology)