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OpenTrials
Completed

NCT Number: NCT00251004

Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

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Key information

Conditions

Kidney Transplantation Graft Rejection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients of any race between 18 to 70 years old (inclusive)
  • Patients who gave written informed consent to participate in the study

Exclusion criteria

  • Recipients of multi-organ transplantation
  • Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
  • Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Everolimus

Drug

oral, bis in diem/twice a day (bid)

Other names: Certican, Zotress

Mycophenolic Acid (MPA)

Drug

2 oral capsules of mycophenolic acid 360mg administered bid

Other names: Myfortic

Cyclosporine A (CsA)

Drug

CsA dose adjustments were based on CsA trough levels (C0).

Other names: Neoral

Basiliximab

Drug

All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.

Other names: Simulect

Corticosteroids

Drug

Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.

Primary outcomes

  1. Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis

    Time frame: 12 months

    The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.

  2. Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints

    Time frame: 12 months

    The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.

Secondary outcomes

  1. Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation

    Time frame: 12 months

    Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.

    A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316.

  2. Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula

    Time frame: at 12 months

    Modification of Diet in Renal Disease (MDRD) formula is:

    GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where

    • C is the serum concentration of creatinine [mg/dL],
    • A is patient age at sample collection date [years],
    • G=0.742 when gender is female, otherwise G=1,
    • R=1.21 when race is black, otherwise R=1

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 9, 2005
Registry last updated
May 10, 2011

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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