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Study Evaluating Rapamune in Patients After Kidney Transplantation

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00240214
Enrollment
500
Registered
2005-10-17
Start date
2001-04-30
Completion date
2008-02-29
Last updated
2008-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

Kidney transplants

Brief summary

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

Interventions

DRUGsirolimus

Tablet, dosage is determined by trough level

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026