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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00154297
First received: September 8, 2005
Last updated: March 30, 2011
Last verified: March 2011

September 8, 2005
March 30, 2011
June 2005
June 2008   (final data collection date for primary outcome measure)
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
"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).
Not Provided
Complete list of historical versions of study NCT00154297 on ClinicalTrials.gov Archive Site
  • Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. [ Time Frame: at 6 Month post-transplantation ] [ Designated as safety issue: No ]

    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
  • Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. [ Time Frame: at 12 Month post-transplantation ] [ Designated as safety issue: No ]

    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
  • Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The number of patients who underwent any dialysis within the 12-month treatment period.
  • Duration of Dialysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The mean duration in days of any dialysis session that occurred within the 12 month treatment period.
  • Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    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.
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Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Everolimus (RAD001)
  • Active Comparator: Immediate Everolimus
    Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
    Intervention: Drug: Everolimus (RAD001)
  • Experimental: Delayed Everolimus
    Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
    Intervention: Drug: Everolimus (RAD001)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
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June 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00154297
CRAD001A2420
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP