Study Evaluating Rapamune in Patients After Kidney Transplantation
NCT00240214
Last updated date
ABOUT THIS STUDY
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under
everyday conditions
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Contraindications according to Summary of the Product Characteristics (SmPC).
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Advanced Information
| 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 | ||||||