Study Evaluating the Use of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (Ecd) - Full Text View

Sponsor:	Wyeth
Collaborator:	3Eff S.A.
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00697112

Purpose

The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppresive treatment with sirolimus.

Condition
Renal Transplant

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Surveillance Registry of Sirolimus (Srl) Use in Recipients of Kidney Allograft From Expanded Criteria Donors (Ecd

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine the one criterion that is considered to be the main reason (out of 10 clinical criteria listed in a questionnaire) for the responsible physician, to introduce sirolimus as base immunosuppressive therapy. [ Time Frame: 12 months recruitment and 12 months follow-up.The total duration of the study will be 24 months approximately. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To examine the different health outcomes using sirolimus therapy in kidney transplantation: acute rejection, patient and graft survival, graft status. To examine the safety of sirolimus as immunosuppressive therapy in kidney transplantation. [ Time Frame: 12 months recruitment and 12 months follow-up.The total duration of the study will be 24 months approximately. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Observational, sirolimus open label one arm study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Kidney allograft recipients

Criteria

Inclusion Criteria:

Recipients age 18 years or older, of a primary,secondary, tertiary,etc. (don't understand what primary/secondary/tertiary refers to), who have received a kidney allograft, without pancreas, from ECD, at least 3 months ago and no later than 1 year at the time of study enrollment;
Patients who provided informed consent;
Patients without sirolimus as base therapy.

Exclusion Criteria:

Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf;
Patients who are unable to complete the study or have participated in another clinical trial during the last 6 months;
Pregnant or lactating patients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697112

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Argentina
	Recruiting
Santa Fé, Argentina, 3000

Sponsors and Collaborators

Wyeth

3Eff S.A.

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	102385
Study First Received:	June 10, 2008
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00697112 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Wyeth:

REGISTRY
KIDNEY ALLOGRAFT
SIROLIMUS

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 February 08, 2010