Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

This study is currently recruiting participants.

Verified by Novartis, September 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170885

Purpose

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Everolimus	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Open-Label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients

Further study details as provided by Novartis:

Primary Outcome Measures:

Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment

Secondary Outcome Measures:

Pharmacokinetics (PK)
Count of CD4 and CD8 positive lymphocytes
Metabolic control: lipids, glycaemic control, proteinuria, enzymes
Ultrasound ejection fraction
Major adverse cardiovascular events

Study Start Date:

May 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
The renal cold ischemic time must be < 36 hours.
The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

Patients who are recipients of multiple organ transplants, including more than one kidney
Patients who have previously received an organ transplant which failed within one year
Patients with current panel reactive T-cell antibody titers of 50% or more
Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170885

Contacts

Contact: Novartis

41 61 324 1111

Locations

Switzerland
Novartis	Recruiting
Basel, Switzerland
Contact: Novartis 41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CRAD001AIT02
Study First Received:	September 9, 2005
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00170885
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Novartis:

acute rejection
renal function
everolimus
cyclosporine microemulsion

Study placed in the following topic categories:

Everolimus
Cyclosporine
Clotrimazole

Miconazole
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009