Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-Coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance. - Full Text View

Purpose

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with EC-MPS and steroids. The study population consists of patients having taken part in study CRAD001A2420 until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Condition	Intervention	Phase
Renal Transplantation	Drug: Everolimus	Phase III

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Everolimus Mycophenolate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective Multicenter Open-Label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With EC-MPS, in Adult Renal Transplant Patients in Maintenance.

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in glomerular filtration rate estimated by iohexol plasma clearance 12 months after randomization between the 2 groups of patients.

Secondary Outcome Measures:

Change in renal function assessed by serum creatinine, creatinine clearance, proteinuria, microalbuminuria, ratio proteinuria/serum creatinine at Month 3, Month 6 and Month12
Incidence and severity of biopsy-proven acute rejection (BPAR) at Month 6 and Month 12.
Incidence of treatment failure assessed by BPAR, graft loss/re-transplantation, death or lost to follow-up at Month 6 and Month 12.
Assessing cardiovascular risk factors based on fasting glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and CRP.
Safety assessed by adverse events and serious adverse events

Estimated Enrollment:	70
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion criteria:

Patients who participated in and completed study CRAD001A2420

Exclusion criteria:

Premature study or study treatment discontinuation in CRAD001A2420 study.
Acute rejection within the 3 months prior to inclusion

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425308

Contacts


Contact: novartis	41613241111

Locations


France
	Novartis Investigative Site	Recruiting
	Paris, France
	Contact: novartis 41613241111

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information

Responsible Party:	novatis ( novartis )
Study ID Numbers:	CRAD001AFR06
First Received:	January 19, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00425308
Health Authority:	France: Afssaps - French Health Products Safety Agency