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WithdrawnNCT00599963

Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study

Status
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.

Conditions

Interventions

TypeNameDescription
DRUGparicalcitolparicalcitol 1 mg/day

Timeline

Start date
2008-01-01
Primary completion
2009-10-01
Completion
2009-12-01
First posted
2008-01-24
Last updated
2015-08-03

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT00599963. Inclusion in this directory is not an endorsement.

Paricalcitol for the Treatment of Immunoglobulin A Nephropathy (NCT00599963) · Clinical Trials Directory