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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00697112

First received: June 10, 2008

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2008

Last Updated Date

March 4, 2013

Start Date ^ICMJE

May 2008

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00697112 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)

Brief Summary

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.

Detailed Description

pilot study

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Kidney allograft recipients

Condition ^ICMJE

Renal Transplantation

Intervention ^ICMJE

Drug: Sirolimus

Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.

Other Name: Rapamune

Study Group/Cohort (s)

Intervention: Drug: Sirolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina

Administrative Information

NCT Number ^ICMJE

NCT00697112

Other Study ID Numbers ^ICMJE

0468H-102385, B1741025

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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