The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
This study has suspended participant recruitment.
(Funding problem; trial abandoned.)
Sponsor:
Chinese University of Hong Kong
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00508898
First received: July 27, 2007
Last updated: January 29, 2009
Last verified: January 2009
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Purpose
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus Nephritis Proteinuria |
Drug: Calcitriol Drug: Multivitamin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- change in proteinuria [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary end points include risk of lupus flare, change in renal function, SLEDAI score, serum and urinary inflammatory markers. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment group
Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
|
Drug: Calcitriol
Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
|
|
Active Comparator: control group
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
|
Drug: Multivitamin
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
|
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
- clinical quiescent SLE for at least 12 weeks
- baseline SLEDAI score <= 4
- history of biopsy-proven lupus nephritis
- estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
- proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker for at least 3 months
- on maintenance dose of prednisolone < 10 mg/day, with or without other immunosuppressive medications
- corrected serum calcium level < 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 4 weeks. Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D.
- 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 More Information
No publications provided
| Responsible Party: | SZETO, Cheuk Chun, The Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00508898 History of Changes |
| Other Study ID Numbers: | CRE-2007.261-T |
| Study First Received: | July 27, 2007 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
lupus nephritis proteinuria chronic kidney diseases SLE |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Lupus Nephritis Nephritis Proteinuria Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Glomerulonephritis Kidney Diseases Urologic Diseases Urination Disorders Urological Manifestations Signs and Symptoms |
Calcitriol 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 |
ClinicalTrials.gov processed this record on May 16, 2013