Study Evaluating Rapamune in Patients After Kidney Transplantation

This study has been terminated.

First Received: October 13, 2005 Last Updated: March 13, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00240214

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:	Cohort, 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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

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

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240214

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com

More Information

No publications provided

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

Keywords provided by Wyeth:

Kidney transplants

Study placed in the following topic categories:

Sirolimus
Anti-Infective Agents
Anti-Bacterial Agents

Immunologic Factors
Antifungal Agents
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009