The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

May 28, 2013 updated by: Alireza Amir Maafi, Guilan University of Medical Sciences
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treatment group
Patients will receive calcitriol at a fixed dose daily.
Drug: calcitriol
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
ACTIVE_COMPARATOR: control group
Patients will receive placebo daily.
Drug: placebo
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in proteinuria
Time Frame: baseline and 12 months
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk of lupus flare
Time Frame: baseline and 12 months
baseline and 12 months
change in renal function
Time Frame: baseline and 12 months
based on the American College of Rheumatology renal response criteria
baseline and 12 months
change in serum inflammatory markers
Time Frame: baseline and 12 months
baseline and 12 months
change in Systemic Lupus Erythematosus Disease Activity Index score
Time Frame: baseline and 12 months
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guilan University of Medical Sciences

Investigators

  • Study Chair: Banafsheh ghavidel parsa, MD, Guilan University of Medical Sciences, Iran
  • Principal Investigator: Alireza Amir Maafi, MD Student, Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (ESTIMATE)

May 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1910354604
  • IRCT2013030912762N1 (REGISTRY: Iranian Registry of Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe