Calcitriol in the Treatment of Immunoglobulin A Nephropathy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Peking University First Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Peking University First Hospital
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT00862693
First received: March 16, 2009
Last updated: February 16, 2011
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glomerulonephritis Autoimmune Diseases |
Drug: Calcitriol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Autoimmune Diseases
Drug Information available for:
Calcitriol
U.S. FDA Resources
Further study details as provided by Peking University First Hospital:
Primary Outcome Measures:
- decline of urine protein [ Time Frame: 12 months treatment ] [ Designated as safety issue: Yes ]analysis urine protein after 12 months treatment
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 calcitriol
calcitriol 0.5ug/BIW for 12 months
|
Drug: Calcitriol
0.5ug/Biw
|
|
No Intervention: 2
no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862693
Contacts
| Contact: Hong Zhang, Prof | +86-10-66551122-2288 | hongzh@bjmu.edu.cn |
Locations
| China, Beijing | |
| Renal Division, Peking University First Hospital | Recruiting |
| Beijing, Beijing, China, 100034 | |
| Contact: Hong Zhang, Prof +86-10-66551122-2288 hongzh@bjmu.edu.cn | |
Sponsors and Collaborators
Peking University First Hospital
More Information
No publications provided
| Responsible Party: | Renal Division, Peking University First Hospital, Key Laboratory of Renal Disease, Ministry of Health of China |
| ClinicalTrials.gov Identifier: | NCT00862693 History of Changes |
| Other Study ID Numbers: | 20090315 |
| Study First Received: | March 16, 2009 |
| Last Updated: | February 16, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Peking University First Hospital:
|
Immunoglobulin A Antibodies treatment |
Additional relevant MeSH terms:
|
Autoimmune Diseases Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Nephritis Kidney Diseases Urologic Diseases Calcitriol Immunoglobulin A Immunoglobulins Antibodies Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013