- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863641
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
- Name: Alireza Amir Maafi, MD Student
- Phone Number: 00989376036481
- Email: alireza.am427@gmail.com
Study Locations
-
-
Guilan
-
Rasht, Guilan, Iran, Islamic Republic of
- Recruiting
- Razi Hospital
-
Contact:
- Alireza Amir Maafi, MD Student
- Phone Number: 00989376036481
- Email: alireza.am427@gmail.com
-
-
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.
|
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.
|
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.
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
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcitriol
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.
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