Study Evaluating Rapamune in Patients After Kidney Transplantation
NCT00240214
ABOUT THIS STUDY
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- Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.
- Contraindications according to Summary of the Product Characteristics (SmPC).
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Descriptive Information | |||||||
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Brief Title | Study Evaluating Rapamune in Patients After Kidney Transplantation | ||||||
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 | ||||||
Brief Summary | The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions | ||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | primary care clinic | ||||||
Condition | Renal Transplantation | ||||||
Intervention | Drug: sirolimus
Tablet, dosage is determined by trough level | ||||||
Study Groups/Cohorts | 1
sirolimus Intervention: Drug: sirolimus | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status | Terminated | ||||||
Actual Enrollment | 500 | ||||||
Original Enrollment | Same as current | ||||||
Actual Study Completion Date | February 2008 | ||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00240214 | ||||||
Other Study ID Numbers | 0468E-100875 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | March 2008 |