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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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19 October 2017 |
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Main ID: |
NCT02081183 |
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Date of registration:
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05/03/2014 |
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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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A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
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Scientific title:
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A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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16 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02081183 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients >=18 years of age;
- diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).
Exclusion Criteria:
- patients who have received cytotoxic drugs in previous 8 weeks;
- systemic infections;
- hepatitis B or C, or HIV.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Nephritis
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Intervention(s)
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Drug: Cyclophosphamide, Induction Phase
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Drug: Cyclophosphamide, Maintenance Phase
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Drug: Prednisone
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Drug: Mycophenolate mofetil (MMF)
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Primary Outcome(s)
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Creatinine Clearance
[Time Frame: 18 months]
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Serum Albumin
[Time Frame: 18 months]
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Urinary Protein
[Time Frame: 18 months]
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Serum Creatinine
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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