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Completed

NCT Number: NCT00154297

Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recipients of cadaveric kidney transplants
  • Patients at risk of DGF defined as one or more of the following:
  • Donor age > 55 years
  • Cold ischemic time (CIT) ≥ 24 hours but < 40 hours
  • Second or subsequent renal transplantation

Exclusion criteria

  • Patients who have received an investigational drug within 4 weeks of baseline period
  • Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
  • Patients with body mass index (BMI) > 32 kg/m2

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Everolimus (RAD001)

Drug

Primary outcomes

  1. Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months

    Time frame: Month 3

    "In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).

Secondary outcomes

  1. Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.

    Time frame: at 6 Month post-transplantation

    The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months:

    • delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
    • efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
    • wound healing disorder related to initial transplant surgery

  2. Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.

    Time frame: at 12 Month post-transplantation

    The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months:

    • delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
    • efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
    • wound healing disorder related to initial transplant surgery

  3. Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period

    Time frame: Month 12

    The number of patients who underwent any dialysis within the 12-month treatment period.

  4. Duration of Dialysis

    Time frame: 12 months

    The mean duration in days of any dialysis session that occurred within the 12 month treatment period.

  5. Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period

    Time frame: Month 12

    A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function

Important dates

Study start
2005
Primary completion
2008
First posted
Sep 12, 2005
Registry last updated
Apr 4, 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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