Systemic Lupus ErythematosusPhase 4NCT00508898
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
A Phase 4 study testing Calcitriol and Multivitamin in people with Systemic Lupus Erythematosus and Nephritis, run by Chinese University of Hong Kong.
Trial summary
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Nephritis, Proteinuria
- What is being tested?
- Calcitriol and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2009
- Phase
- Phase 4
- 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
- clinical quiescent SLE for at least 12 weeks
- baseline SLEDAI score <= 4
- history of biopsy-proven lupus nephritis
- estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
- proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker for at least 3 months
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- on maintenance dose of prednisolone < 10 mg/day, with or without other immunosuppressive medications
- corrected serum calcium level < 2.45 mmol/l
- 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
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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
About this study
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.
- Conditions
- Systemic Lupus Erythematosus, Nephritis, Proteinuria
- Being tested
- Calcitriol, Multivitamin
- Keywords
- lupus nephritis, proteinuria, chronic kidney diseases, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic, Nephritis, Proteinuria, Lupus Nephritis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
MultivitaminDrug
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly. Receives: Drug: Calcitriol |
| control group | Active comparator | Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU). Receives: Drug: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in proteinuria
Measured: one year
Secondary outcomes (1)
Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Funding problem; trial abandoned.
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Cheuk-Chun Szeto, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508898
- Sponsor's protocol ID
- CRE-2007.261-T
- Status last verified
- Jan 2009
- First submitted
- 27 Jul 2007
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
- ClinicalTrials.gov ID
- NCT00508898
- Acronym / sponsor ID
- CRE-2007.261-T
- Conditions
- Systemic Lupus Erythematosus, Nephritis, Proteinuria
- Keywords
- lupus nephritis, proteinuria, chronic kidney diseases, SLE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding problem; trial abandoned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Jul 2007 (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.
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: CalcitriolPatients will receive calcitriol at a fixed dose of 1 mcg twice weekly. |
| control group | Active comparator | Drug: MultivitaminPatients will receive multivitamin 1 tab daily (with vitamin D2 300 IU). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged 18-65 years
- clinical quiescent SLE for at least 12 weeks
- baseline SLEDAI score <= 4
- history of biopsy-proven lupus nephritis
- estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
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
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 (oral capsule) at a fixed dose of 1 mcg twice weekly. | Drug | treatment group |
| MultivitaminPatients will receive multivitamin 1 tab daily (with vitamin D2 300 IU). | Drug | control group |
Primary outcome
change in proteinuria
Time frame: one year
1 secondary outcome
Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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.
Cheuk-Chun Szeto, MD principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol and Multivitamin in people with Systemic Lupus Erythematosus and Nephritis, run by Chinese University of Hong Kong.
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 9 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: withdrawn, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in proteinuria (time frame: one year). 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 4 Aug 2015.