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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 February 2015 |
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Main ID: |
NCT00141804 |
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Date of registration:
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31/08/2005 |
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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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Efficacy and Safety of Sirolimus in Combination With Tacrolimus
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Scientific title:
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A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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190 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00141804 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Heiner H. Wolters, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Muenster |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- first kidney transplantation
- re-transplantation
- non-related living donor transplantation
- patients > 18 years
- patients have given their written consent after being informed
- female patients in the age of parity must consent to an effective birth control and
submit a negative pregnancy test
Exclusion Criteria:
- related living donation
- patients with known HIV-anamnesis
- patients who need systemically administered immunosuppression for another indication
than the prophylaxis of kidney graft rejection
- patients with present malignant disease
- patients with clinically significant, uncontrolled infectional disease and/or severe
diarrhea, vomiting or active gastric ulcer
- patients who haven taken part in a clinical study in the past 28 days and/or receive
(received) medication which is not licensed by the responsible health authority
- other reasons which depend on the assessment of the physician
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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Kidney Transplantation
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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- discontinuation of study medication at month 12
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- graft failure at month 12
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- time to first biopsy proven acute rejection episode at month 12
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Secondary Outcome(s)
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- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
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- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
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- patient and graft survival at month 12
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- incidence and severity of infections at month 12
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- incidence of adverse events at month 12
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Secondary ID(s)
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contract number DE-02-RG-74
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SirTac 01
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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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