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NCT00240214 Clinical Trial

Study Evaluating Rapamune in Patients After Kidney Transplantation

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00240214
Other study ID # 0468E-100875
Secondary ID
Status Terminated
Phase N/A
First received October 13, 2005
Last updated March 13, 2008
Start date April 2001
Est. completion date February 2008

Study information
Verified date March 2008
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions

Recruitment information / eligibility
Status Terminated
Enrollment 500
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.

Exclusion Criteria:

- Contraindications according to Summary of the Product Characteristics (SmPC).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• sirolimus
Tablet, dosage is determined by trough level

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

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