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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00240214 |
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
Condition | Intervention |
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Renal Transplantation |
Drug: sirolimus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime |
Enrollment: | 500 |
Study Start Date: | April 2001 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
sirolimus
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Drug: sirolimus
Tablet, dosage is determined by trough level
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0468E-100875 |
Study First Received: | October 13, 2005 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00240214 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Kidney transplants |
Sirolimus Anti-Bacterial Agents Immunologic Factors Clotrimazole |
Miconazole Antifungal Agents Tioconazole Immunosuppressive Agents |
Sirolimus Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |