- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862693
Calcitriol in the Treatment of Immunoglobulin A Nephropathy
February 16, 2011 updated by: Peking University First Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Recruiting
- Renal Division, Peking University First Hospital
-
Contact:
- Hong Zhang, Prof
- Phone Number: +86-10-66551122-2288
- Email: hongzh@bjmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
no intervention
|
|
Experimental: 1 calcitriol
calcitriol 0.5ug/BIW for 12 months
|
0.5ug/Biw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decline of urine protein
Time Frame: 12 months treatment
|
analysis urine protein after 12 months treatment
|
12 months treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
August 1, 2010
Study Completion (Anticipated)
March 1, 2011
Study Registration Dates
First Submitted
March 16, 2009
First Submitted That Met QC Criteria
March 16, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Estimate)
February 17, 2011
Last Update Submitted That Met QC Criteria
February 16, 2011
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Kidney Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Autoimmune Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcitriol
Other Study ID Numbers
- 20090315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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