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

Renal Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154297
• Other study ID #: CRAD001A2420
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: March 30, 2011
• Start date: June 2005

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Everolimus (RAD001)

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months	"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).	Month 3	No
Secondary	Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months 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	at 6 Month post-transplantation	No
Secondary	Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months 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	at 12 Month post-transplantation	No
Secondary	Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period	The number of patients who underwent any dialysis within the 12-month treatment period.	Month 12	No
Secondary	Duration of Dialysis	The mean duration in days of any dialysis session that occurred within the 12 month treatment period.	12 months	No
Secondary	Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period	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.	Month 12	Yes