Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170820

Purpose

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Condition	Intervention	Phase
Renal Transplantation	Drug: Everolimus	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Everolimus Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm, Prospective, Open-Label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Further study details as provided by Novartis:

Primary Outcome Measures:

Renal function at M6 (glomerular filtration and tubular function).

Secondary Outcome Measures:

Renal function (other tubular function parameters)
Incidence of biopsy-proven acute rejections and CMV infections
Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH
Mucous and cutaneous disorders
Adverse events and serious adverse events, premature study treatment discontinuations.
Monitoring of everolimus trough levels.

Estimated Enrollment:	20
Study Start Date:	February 2005

Eligibility

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

Criteria

Inclusion Criteria:

First or second renal transplantation (1 to 10 years post-transplant)
Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

Treatment with a CNI or azathioprine
Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170820

Locations

Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	CRAD001AFR04
Study First Received:	September 9, 2005
Last Updated:	February 6, 2007
ClinicalTrials.gov Identifier:	NCT00170820
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Renal transplantation, maintenance, switch, everolimus, CNI-free

Study placed in the following topic categories:

Everolimus
Sirolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009