Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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10 August 2015 |
Main ID: |
NCT00508898 |
Date of registration:
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27/07/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
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Scientific title:
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The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria |
Date of first enrolment:
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May 2008 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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https://clinicaltrials.gov/show/NCT00508898 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Cheuk-Chun Szeto, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Chinese University of Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 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
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
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nephritis
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Proteinuria
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Multivitamin
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Drug: Calcitriol
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Primary Outcome(s)
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change in proteinuria
[Time Frame: one year]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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CRE-2007.261-T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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