Systemic Lupus ErythematosusPhase 2NCT01863641
The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
A Phase 2 study testing calcitriol in people with Systemic Lupus Erythematosus, run by Guilan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Apr 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Razi hospital
Rasht, Gilan Province
Alireza Amir Maafi, MD Student, 00989376036481, alireza.am427@gmail.com
About this study
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.
Read the 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
- Being tested
- calcitriol, placebo
- Keywords
- lupus nephritis, proteinuria, SLE, calcitriol
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDrug
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
placeboDrug
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients will receive calcitriol at a fixed dose daily. Receives: Drug: calcitriol |
| control group | Active comparator | Patients will receive placebo daily. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in proteinuria
Measured: baseline and 12 months
Secondary outcomes (4)
risk of lupus flare
Measured: baseline and 12 months
change in renal function
based on the American College of Rheumatology renal response criteria
Measured: baseline and 12 months
change in serum inflammatory markers
Measured: baseline and 12 months
change in Systemic Lupus Erythematosus Disease Activity Index score
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guilan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Amir Maafi, Guilan University of Medical Sciences
- Investigators
- Banafsheh ghavidel parsa, MD, Study chair, Guilan University of Medical Sciences, IranAlireza Amir Maafi, MD Student, Principal investigator, Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863641
- Sponsor's protocol ID
- 1910354604
- Other IDs
- IRCT2013030912762N1
- Status last verified
- May 2013
- First submitted
- 17 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01863641
- Acronym / sponsor ID
- 1910354604
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus nephritis, proteinuria, SLE, calcitriol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guilan University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: calcitriolPatients will receive calcitriol at a fixed dose daily. |
| control group | Active comparator | Drug: placeboPatients will receive placebo daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcitriolPatients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily. | Drug | treatment group |
| placeboPatients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily. | Drug | control group |
Primary outcome
change in proteinuria
Time frame: baseline and 12 months
4 secondary outcomes
risk of lupus flare
Time frame: baseline and 12 months
change in renal function
Time frame: baseline and 12 months
change in serum inflammatory markers
Time frame: baseline and 12 months
change in Systemic Lupus Erythematosus Disease Activity Index score
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banafsheh ghavidel parsa, MD study chair
Guilan University of Medical Sciences, Iran
Alireza Amir Maafi, MD Student principal investigator
Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitriol in people with Systemic Lupus Erythematosus, run by Guilan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Amir Maafi, MD Student (00989376036481, alireza.am427@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in proteinuria (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.