Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00599963
• Other study ID #: CRE-2007.409-T
• Secondary ID: CRE-2007.409-T
• Status: Withdrawn
• Phase: Phase 3
• First received: January 2, 2008
• Last updated: July 31, 2015
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• paricalcitol
paricalcitol 1 mg/day

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the degree of proteinuria		12 weeks	Yes
Secondary	rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers		12 weeks	Yes