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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00254709

Enrollment

Registered

2005-11-16

Start date

2002-10-31

Completion date

2005-09-30

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged, Graft Rejection, Kidney Failure

Keywords

kidney transplant, elderly

Brief summary

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

Interventions

DRUGSirolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026