To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00296361

Acronym

RESTORE

Enrollment

634

Registered

2006-02-27

Start date

2004-10-31

Completion date

2006-07-31

Last updated

2014-09-01

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

Conditions

Kidney Transplantation

Keywords

Tacrolimus, Kidney Transplantation, Immunosuppression, Adult, Treatment Outcomes

Brief summary

Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

Detailed description

This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.

Interventions

DRUGTacrolimus

immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients between 18 and 60 years of age and having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.

Exclusion criteria

* Patient has a high immunological risk * Cold ischemia time greater than 30 hours * Patient has significant liver disease * Patient has severe hypercholesterolaemia * Patient is allergic or intolerant to study medication * Patient requires ongoing dosing with corticosteroids. * Patient or donor is known to be HIV positive * Patient with malignancy or history of malignancy

Design outcomes

Primary

Measure	Time frame
Renal function as assessed by calculated creatinine clearance at month 6.	6 months

Secondary

Measure	Time frame
Acute rejection: Incidence of and time to first acute rejection	6 months

Countries

Australia, Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom

Outcome results

None listed

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