Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

This study is currently recruiting participants.

Verified by Wyeth, December 2007

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195195

Purpose

The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.

Condition	Intervention	Phase
Transplantation	Drug: Sirolimus	Phase IV

Drug Information available for: Sirolimus

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Sirolimus	Drug: Sirolimus Transplantation patients treated with sirolimus who consent to participate in the study (register)

Eligibility

Study Population

Transplantation patients treated with sirolimus.

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195195

Contacts

Contact: Trial Manager

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468-101157
Study First Received:	September 12, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00195195
Health Authority:	Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency

Keywords provided by Wyeth:

Transplantation

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Miconazole
Tioconazole

Additional relevant MeSH terms:

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 January 16, 2009