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OpenTrials
Completed

NCT Number: NCT00296361

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nedlands, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

immunosuppression

Other names: Prograf, FK506

Primary outcomes

  1. Renal function as assessed by calculated creatinine clearance at month 6.

    Time frame: 6 months

Secondary outcomes

  1. Acute rejection: Incidence of and time to first acute rejection

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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.

Acronym: RESTORE

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 27, 2006
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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