Status:
UNKNOWN
Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Lead Sponsor:
Peking University First Hospital
Conditions:
Glomerulonephritis
Autoimmune Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 gl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00862693
Start Date
March 1 2009
End Date
March 1 2011
Last Update
February 17 2011
Active Locations (1)
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1
Renal Division, Peking University First Hospital
Beijing, Beijing Municipality, China, 100034