The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guilan University of Medical Sciences
• Treatments: Calcitriol

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