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RESCUE Study - Everolimus in Liver Transplant Recipients With Renal Insufficiency
This study is currently recruiting participants.
Verified by Novartis, December 2008
Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00267189
  Purpose

The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.


Condition Intervention Phase
Liver Transplantation
Drug: Everolimus (RAD001)
Phase III

MedlinePlus related topics: Liver Transplantation
Drug Information available for: Everolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 6-Month, Multicenter, Randomized, Open-Label Study of Safety and Efficacy of Everolimus-Based Regimen Versus Calcineurin Inhibitor (CNI)-Based Regimen in Maintenance Liver Transplant Recipients

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function assessed by calculated Glomerular Filtration Rate (cGFR) from Baseline to Month 6 after randomization

Secondary Outcome Measures:
  • Incidence of efficacy failure (Biopsy Proven Acute Rejection [BPAR], graft loss or death)
  • Incidence of treated BPAR
  • Patient and graft survival
  • Safety parameters including : hypertension, diabetes mellitus, hyperlipidemia, anemia, infections and malignancies
  • Incidence of discontinuation of study medication

Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion criteria

  • Male or female 18 - 70 years old
  • Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor
  • Patient with a calculated GFR £ 60 and ³ 20mL/min
  • Patient receiving tacrolimus with C0-h level ³ 3 and £ 8 ng/mL or cyclosporine microemulsion with C0-h level ³ 50 and £ 150 ng/mL with or without any of the following (mycophenolic acid or azathioprine or steroids)
  • Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 6 months
  • Patient in whom an allograft biopsy will not be contraindicated
  • Female capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study

Exclusion criteria

  • Recipient of multiple solid organ transplants
  • Patient on dialysis
  • Patient with an identifiable cause of renal dysfunction other than CNI toxicity
  • Patient with proteinuria ³ 1.0 g/24h
  • Patient with any acute rejection within 6 months prior to randomization
  • Patient with platelet count of ≤ 50,000/mm³ or white blood cell count of ≤ 2,000/mm³ or hemoglobin value ≤ 8 g/dL
  • Patient with graft dysfunction associated with bilirubin > 34 mmol/L, or albumin < 35 g/L or prothrombin time > 1.3 INR
  • HCV positive patient who needs an active anti-viral treatment
  • HIV positive patient
  • Patient who is breast feeding
  • Patient with a current severe systemic infection
  • Patient who has received an unlicensed drug or therapy within one month prior to study entry
  • Presence of any hypersensitivity to drugs similar to everolimus (e.g. macrolides)
  • Use of any other immunosuppressive drugs than tacrolimus/cyclosporine microemulsion, steroids, azathioprine and mycophenolic acid Additional protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267189

Contacts
Contact: Novarts Pharmaceuticals 41 61 324 11 11

Locations
Germany
Novartis Investigational Site Recruiting
Germany, Germany
Contact: Novartis Pharmaceuticals     41613241111        
Switzerland
Novartis Investigative Site Recruiting
Basel, Switzerland
Contact: Novartis Pharmaceuticals     41 61 324 11 11        
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CRAD001H2401
Study First Received: December 19, 2005
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00267189  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:
Liver transplantation, everolimus, calcineurin inhibitor, renal function

Study placed in the following topic categories:
Everolimus
Renal Insufficiency

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009