The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Primary Purpose
Systemic Lupus Erythematosus, Nephritis, Proteinuria
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Calcitriol
Multivitamin
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus nephritis, proteinuria, chronic kidney diseases, SLE
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
treatment group
control group
Arm Description
Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
Outcomes
Primary Outcome Measures
change in proteinuria
Secondary Outcome Measures
Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.
Full Information
NCT ID
NCT00508898
First Posted
July 27, 2007
Last Updated
July 31, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00508898
Brief Title
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Official Title
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Funding problem; trial abandoned.
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Nephritis, Proteinuria
Keywords
lupus nephritis, proteinuria, chronic kidney diseases, SLE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Description
Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
Intervention Type
Drug
Intervention Name(s)
Multivitamin
Intervention Description
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
Primary Outcome Measure Information:
Title
change in proteinuria
Time Frame
one year
Secondary Outcome Measure Information:
Title
Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk-Chun Szeto, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
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