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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Everolimus in de Novo Kidney Transplant Recipients

NCT01410448

Kidney Transplantation

COMPLETED PHASE3

Everolimus in de Novo Heart Transplant Recipients

NCT01017029

Cardiac Transplantation

COMPLETED PHASE4

Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

NCT00956293

Renal Transplantation

TERMINATED PHASE4

Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

NCT03596970

Liver Transplantation

WITHDRAWN PHASE3

Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.

NCT00170794

Cardiac Transplantation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Everolimus (RAD001)

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Everolimus (RAD001)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No