Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

Phase 3

Withdrawn

• Conditions: IgA Nephropathy
• Interventions: Drug: paricalcitol

• Registration Number: NCT00599963
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-24
• Status Verified: 2009-01
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• aged 18-65 years
• biopsy-confirmed IgA nephropathy
• proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
• estimated glomerular filtration rate > 60 ml/min/1.73m2
• corrected serum calcium level > or = 2.45 mmol/l
• willingness to give written consent and comply with the study protocol

Exclusion Criteria

• Pregnancy, lactating or childbearing potential without effective method of birth control
• Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
• History of malignancy, including leukemia and lymphoma within the past 2 years
• Systemic infection requiring therapy at study entry
• Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
• History of drug or alcohol abuse within past 2 years
• Participation in any previous trial on paricalcitol
• Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
• Patients receiving treatment of corticosteroid
• On other investigational drugs within last 30 days
• History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
• History of non-compliance
• Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	paricalcitol	paricalcitol 1 mg/day for 12 weeks, followed by a washout period of 4 weeks, then crossed over to no treatment for another 12 weeks
2	paricalcitol	no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks

Primary Outcome Measures

Name	Time	Method
change in the degree of proteinuria	12 weeks

Secondary Outcome Measures

Name	Time	Method
rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers	12 weeks

Trial Locations

Locations (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong