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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2015 |
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Main ID: |
NCT00125307 |
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Date of registration:
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29/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
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Scientific title:
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Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00125307 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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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China
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Hong Kong
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Contacts
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Name:
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Cheuk-Chun Szeto, MD |
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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:
- Fulfill the revised American College of Rheumatology criteria for SLE
- Have biopsy-proven membranous nephropathy secondary to SLE
- Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or
without active urinary sediments despite steroid therapy (with or without cytotoxic
agents)
- Age over 18 with informed consent
- Female patients of child-bearing age and male patients who agree to maintain
effective birth control practice during the study
Exclusion Criteria:
- Patient with abnormal liver function tests
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
- Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other
agents known to influence urinary protein excretion
- Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Lupus Nephritis
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Intervention(s)
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Drug: tacrolimus
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Primary Outcome(s)
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Change in 24-hour urinary protein excretion
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Secondary Outcome(s)
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Development of non-renal flare
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Development of renal flare
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Secondary ID(s)
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CRE-2004.229-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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