Calcitriol in the Treatment of Immunoglobulin A Nephropathy

NCT ID: NCT00862693

Last Updated: 2011-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

Brief Summary

Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.

Conditions

Glomerulonephritis; Autoimmune Diseases

Study Design

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

Study Groups

1 calcitriol

calcitriol 0.5ug/BIW for 12 months

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DRUG

0.5ug/Biw

2

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Calcitriol

0.5ug/Biw

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18-65 years
• Biopsy-confirmed IgA nephropathy
• Proteinuria > 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or 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

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Key Laboratory of Renal Disease, Ministry of Health of China

Locations

Renal Division, Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Zhang, Prof

Role: CONTACT

hongzh@bjmu.edu.cn

+86-10-66551122-2288

Facility Contacts

Hong Zhang, Prof

Role: primary

hongzh@bjmu.edu.cn

+86-10-66551122-2288

References

Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Reference Type: DERIVED

PMID: 38299639 (View on PubMed)

Other Identifiers

20090315

Identifier Type: -

Identifier Source: org_study_id