Efficacy and Safety Study of Everolimus Plus Cyclosporine and Mycophenolic Acid Plus Cyclosporine in Kidney Transplants

This study is ongoing, but not recruiting participants.

First Received: November 7, 2005 Last Updated: July 11, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00251004

Purpose

The purpose of this study is to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

Condition	Intervention	Phase
Kidney Transplantation Graft Rejection	Drug: Everolimus	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety Study Comparing Concentration-Controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid Cyclosporine Cyclosporin Everolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

treated biopsy acute rejection, graft loss, and survival within 12 months

Secondary Outcome Measures:

graft loss, survival, and renal function at 12 months

Estimated Enrollment:	825
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2008

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male and female patients of any race between 18 to 70 years old (inclusive)
Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
Patients who give written informed consent to participate in the study

Exclusion Criteria:

Recipients of multi-organ transplantation
Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251004

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CRAD001A2309
Study First Received:	November 7, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00251004 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Renal transplantation, kidney, and organ transplant
Renal transplant rejection

Study placed in the following topic categories:

Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Cyclosporine
Immunologic Factors

Antifungal Agents
Mycophenolic Acid
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Everolimus
Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors

Antibiotics, Antineoplastic
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 10, 2009