The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

NCT ID: NCT01863641

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

treatment group

Patients will receive calcitriol at a fixed dose daily.

Group Type: EXPERIMENTAL

calcitriol

Intervention Type: DRUG

Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.

control group

Patients will receive placebo daily.

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.

Interventions

calcitriol

Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.

Intervention Type: DRUG

placebo

Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guilan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Alireza Amir Maafi

Minister of Student Research Committee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Banafsheh ghavidel parsa, MD

Role: STUDY_CHAIR

Guilan University of Medical Sciences, Iran

Alireza Amir Maafi, MD Student

Role: PRINCIPAL_INVESTIGATOR

Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran

Locations

Razi hospital

Rasht, Gilan Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Alireza Amir Maafi, MD Student

Role: CONTACT

alireza.am427@gmail.com

00989376036481

Facility Contacts

Alireza Amir Maafi, MD Student

Role: primary

alireza.am427@gmail.com

00989376036481

Other Identifiers

IRCT2013030912762N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

1910354604

Identifier Type: -

Identifier Source: org_study_id