Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD) - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
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 immunosuppressive treatment with sirolimus.

Condition	Intervention	Phase
Renal Transplantation	Drug: Sirolimus	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)

Resource links provided by NLM:

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

A questionnaire completion: the Principal Investigator will specify the main reason for the use of sirolimus and check one option of eleven different options [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glomerular Filtration Rate at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient Survival by Kaplan Meyer Analysis at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Graft Survival by Kaplan Meyer Analysis at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: Sirolimus Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling. Other Name: Rapamune

Detailed Description:

pilot 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:

Patients aged 18 years or older.
Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior 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.
Patients who are participating 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: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Argentina
Pfizer Investigational Site	Recruiting
Caba, Buenos Aires, Argentina, C1093AAS
Pfizer Investigational Site	Recruiting
Caba, Buenos Aires, Argentina
Pfizer Investigational Site	Recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Pfizer Investigational Site	Recruiting
Caba, Buenos Aires, Argentina, 1425
Pfizer Investigational Site	Active, not recruiting
Barrio General Paz, Cordoba, Argentina, 5016
Pfizer Investigational Site	Active, not recruiting
Cordoba, Argentina, 5016
Pfizer Investigational Site	Recruiting
Santa Fe, Argentina, 3000
Pfizer Investigational Site	Recruiting
Tucuman, Argentina, 4000

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00697112 History of Changes
Other Study ID Numbers:	0468H-102385, B1741025
Study First Received:	June 10, 2008
Last Updated:	May 22, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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 May 23, 2012