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

Phase 4

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Everolimus (RAD001)

• Registration Number: NCT00154297
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2008-06
• Results First Submitted: 2011-01-04
• Results First Submitted QC: 2011-01-04
• Results First Posted: 2011-01-26
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-30
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Everolimus	Everolimus (RAD001)	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.
Immediate Everolimus	Everolimus (RAD001)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months	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 Outcome Measures

Name	Time	Method
Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.	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
Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.	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
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period	Month 12	The number of patients who underwent any dialysis within the 12-month treatment period.
Duration of Dialysis	12 months	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	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.

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland