Clinical trial NCT01863641: The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
Official title: The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: lupus nephritis
proteinuria
SLE
calcitriol
Lead sponsor: Guilan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in proteinuria
timeFrame: baseline and 12 months
Secondary outcomes:
measure: risk of lupus flare
timeFrame: baseline and 12 months
measure: change in renal function
timeFrame: baseline and 12 months
measure: change in serum inflammatory markers
timeFrame: baseline and 12 months
measure: change in Systemic Lupus Erythematosus Disease Activity Index score
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Razi hospital
state: Guilan
Study officials:
affiliation: Guilan University of Medical Sciences, Iran
name: Banafsheh ghavidel parsa, MD
role: STUDY_CHAIR
affiliation: Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran
name: Alireza Amir Maafi, MD Student
role: PRINCIPAL_INVESTIGATOR
References: