Home
Clinical Trials
A Facilitated Access Program ...

A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Related Clinical Trials

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

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WITHDRAWN PHASE3

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

NCT00154297

Renal Transplantation

COMPLETED PHASE4

Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients

NCT00170833

Renal Transplantation

COMPLETED PHASE3

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

This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

NCT00531063

Renal Transplantation

COMPLETED PHASE3

Detailed Description

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

This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

* To provide everolimus maintenance therapy through this access program and
* To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
* To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Conditions

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

Organ Transplantation

Interventions

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

everolimus (RAD)

Everolimus

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Male or female recipients of solid organ transplants
* Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
* Currently on investigational drug everolimus (RAD) therapy

Exclusion Criteria

* Inability or unwillingness to comply with immunosuppressive regimen.
* Pregnancy.
* History of acute organ rejection within the last 3 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Birmingham, Alabama, United States

Site Status