Status:
COMPLETED
Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
IGA Nephropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune sy...
Detailed Description
This is a open-label and single arm study. We plan to recruit 10 patients with biopsy-proven IgA nephropathy will be recruited. Treatment regimen and dosage adjustment At week 0, all patients will r...
Eligibility Criteria
Inclusion
- aged 18-65 years
- biopsy-confirmed IgA nephropathy
- proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
- estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
- corrected serum calcium level M 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 vitamin D analogue
- 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 vitamin D analogs
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00319761
Start Date
May 1 2006
End Date
September 1 2007
Last Update
January 30 2009
Active Locations (1)
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1
Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, Hong Kong