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Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

Primary Purpose

Kidney Failure, Graft Rejection, Aged

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sirolimus

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring kidney transplant, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: End stage renal disease Kidney transplantation Both donor and recipient older than 60 years Exclusion Criteria: Prior or concurrent transplant of any organ other than the kidney Current clinically significant infections

Sites / Locations

Outcomes

Primary Outcome Measures

Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcome Measures

Incidence of acute rejections at 3 and 12 months

Patient and graft survival at 3 and 12 months

Incidence and duration of episodes of acute tubular necrosis

Time to recover renal function (creatinine< 2 mg/dl)

Full Information

NCT ID

NCT00254709

First Posted

November 11, 2005

Last Updated

January 26, 2012

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00254709

Brief Title

Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

Official Title

Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Graft Rejection, Aged

Keywords

kidney transplant, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Primary Outcome Measure Information:

Title

Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcome Measure Information:

Title

Incidence of acute rejections at 3 and 12 months

Title

Patient and graft survival at 3 and 12 months

Title

Incidence and duration of episodes of acute tubular necrosis

Title

Time to recover renal function (creatinine< 2 mg/dl)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

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