Efficacy and Safety of Enteric-Coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00413920

Purpose

This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

Condition	Intervention	Phase
Renal Transplantation	Drug: Enteric-coated mycophenolate sodium (EC-MPS)	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate sodium Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-Coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of treatment failures defined by biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up [ Time Frame: at 6 months post transplantation ]

Secondary Outcome Measures:

BPAR, clinical acute rejection (AR) and treated AR and severity [ Time Frame: at 3 and 6 months ]
Subclinical histological rejections [ Time Frame: at month 3 ]
Graft and patient survival [ Time Frame: at 3 and 6 months ]
Rate of patients requiring steroids in non-steroid treatment group [ Time Frame: at month 6 ]
Safety assessed by adverse events (AEs), serious adverse events (SAEs), infections, premature study treatment discontinuations due to safety reasons (AE, death, graft loss, abnormal laboratory test value) and steroid side effects [ Time Frame: within the 6 months ]

Estimated Enrollment:	210
Study Start Date:	April 2007

Eligibility

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

Criteria

Inclusion Criteria:

Primary donor kidney transplant
Panel reactive antibody (PRA) ≤ 20%

Exclusion Criteria:

Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
Non-heart beating donor or kidney from a non-compatible donor

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413920

Contacts

Contact: Novartis

41 61 324 1111

Locations

France
C.H.U. La Milétrie	Recruiting
Poitiers, France
Contact: Novartis 05 49 44 44 36

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceticals ( External Affairs )
Study ID Numbers:	CERL080AFR05
Study First Received:	December 19, 2006
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00413920 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Steroids avoidance,
enteric-coated mycophenolate sodium (EC-MPS),
de novo renal transplantation

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Mycophenolate mofetil
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Mycophenolate mofetil

Enzyme Inhibitors
Immunosuppressive Agents
Cyclosporins
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009