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

Novartis Pharmaceuticals139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

139

Conditions

Renal Transplantation

Interventions

Everolimus (RAD001)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: Month 3

Secondary Outcomes

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

Time frame: at 6 Month post-transplantation

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

Time frame: at 12 Month post-transplantation

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.