Status:
UNKNOWN
The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
Lead Sponsor:
Guilan University of Medical Sciences
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.
Detailed Description
Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its an...
Eligibility Criteria
Inclusion
- Aged 18-65 years
- Baseline Systemic Lupus Erythematosus Disease Activity Index score \<= 4
- Estimated glomerular filtration rate more than 15 ml/min/1.73m2
- Proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
- On maintenance dose of prednisolone \< 15 mg/day with or without other immunosuppressive medications
- Serum calcium level in normal range( 8.5-10.5 mg/dl)
- History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
- 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
- Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01863641
Start Date
April 1 2013
End Date
April 1 2014
Last Update
May 29 2013
Active Locations (1)
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1
Razi hospital
Rasht, Gilan Province, Iran