Study Evaluating Rapamune in Patients After Kidney Transplantation

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00240214
First received: October 13, 2005
Last updated: March 13, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention
Renal Transplantation
Drug: sirolimus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 500
Study Start Date: April 2001
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
sirolimus
Drug: sirolimus
Tablet, dosage is determined by trough level

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240214

Locations
Germany
Multiple Cities, Germany
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00240214     History of Changes
Other Study ID Numbers: 0468E-100875
Study First Received: October 13, 2005
Last Updated: March 13, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney transplants

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014