Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy
This study has been completed.
Sponsor:
Chinese University of Hong Kong
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00319761
First received: April 27, 2006
Last updated: January 29, 2009
Last verified: January 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 system function and glomerular mesangial cell proliferation. Calcitriol, an active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the investigators plan to conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 12 weeks. 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 is a major cause of dialysis-dependent renal failure.
| Condition | Intervention | Phase |
|---|---|---|
|
IGA Nephropathy |
Drug: Calcitriol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A Nephropathy |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Primary end point of the study is the change in the degree of proteinuria.
Secondary Outcome Measures:
- Secondary end points include the change in renal function and other serum inflammatory markers.
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description 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 > 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 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319761
Locations
| Hong Kong | |
| Department of Medicine & Therapeutics, Prince of Wales Hospital | |
| Hong Kong, Hong Kong | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Cheuk-Chun Szeto, MD | Chinese University of Hong Kong |
More Information
No publications provided by Chinese University of Hong Kong
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. CC Szeto, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00319761 History of Changes |
| Other Study ID Numbers: | CREC-2006.120 |
| Study First Received: | April 27, 2006 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
glomerulonephritis proteinuria chronic kidney diseases |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis Urologic Diseases Autoimmune Diseases Immune System 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 May 19, 2013