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The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
calcitriol
placebo
Sponsored by
Guilan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus nephritis, proteinuria, SLE, calcitriol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Razi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group

control group

Arm Description

Patients will receive calcitriol at a fixed dose daily.

Patients will receive placebo daily.

Outcomes

Primary Outcome Measures

change in proteinuria

Secondary Outcome Measures

risk of lupus flare
change in renal function
based on the American College of Rheumatology renal response criteria
change in serum inflammatory markers
change in Systemic Lupus Erythematosus Disease Activity Index score

Full Information

First Posted
May 17, 2013
Last Updated
May 28, 2013
Sponsor
Guilan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01863641
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guilan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
lupus nephritis, proteinuria, SLE, calcitriol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients will receive calcitriol at a fixed dose daily.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients will receive placebo daily.
Intervention Type
Drug
Intervention Name(s)
calcitriol
Intervention Description
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
Primary Outcome Measure Information:
Title
change in proteinuria
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
risk of lupus flare
Time Frame
baseline and 12 months
Title
change in renal function
Description
based on the American College of Rheumatology renal response criteria
Time Frame
baseline and 12 months
Title
change in serum inflammatory markers
Time Frame
baseline and 12 months
Title
change in Systemic Lupus Erythematosus Disease Activity Index score
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Amir Maafi, MD Student
Phone
00989376036481
Email
alireza.am427@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banafsheh ghavidel parsa, MD
Organizational Affiliation
Guilan University of Medical Sciences, Iran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alireza Amir Maafi, MD Student
Organizational Affiliation
Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Razi hospital
City
Rasht
State/Province
Guilan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Amir Maafi, MD Student
Phone
00989376036481
Email
alireza.am427@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

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