The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
- 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).
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| 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:
| ||||||
| Sex/Gender |
| ||||||
| 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 |
| ||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | March 2008 | ||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
