Systemic Lupus Erythematosus
Conditions
Keywords
lupus nephritis, proteinuria, SLE, calcitriol
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 analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.
Interventions
DRUGcalcitriol
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
DRUGplacebo
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
Sponsors
Guilan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in proteinuria | baseline and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| risk of lupus flare | baseline and 12 months | — |
| change in renal function | baseline and 12 months | based on the American College of Rheumatology renal response criteria |
| change in serum inflammatory markers | baseline and 12 months | — |
| change in Systemic Lupus Erythematosus Disease Activity Index score | baseline and 12 months | — |
Countries
Iran
Contacts
Primary ContactAlireza Amir Maafi, MD Student
Outcome results
None listed