Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

NCT ID: NCT00599963

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

IgA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

paricalcitol

Intervention Type: DRUG

paricalcitol 1 mg/day

2

no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks

Group Type: ACTIVE_COMPARATOR

paricalcitol

Intervention Type: DRUG

paricalcitol 1 mg/day

Interventions

paricalcitol

paricalcitol 1 mg/day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

The Chinese University of Hong Kong

Principal Investigators

Cheuk Chun Szeto, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

CRE-2007.409-T

Identifier Type: -

Identifier Source: secondary_id

CRE-2007.409-T

Identifier Type: -

Identifier Source: org_study_id