Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00228020

Purpose

The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.

Condition	Intervention	Phase
Pediatric Kidney Transplantation	Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) Drug: MMF, cyclosporine, steroids	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Prednisone Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Basiliximab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to first BPAR episode or treatment failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).

Enrollment:	212
Study Start Date:	May 2001
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Basiliximab Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids	Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
Active Comparator: Basiliximab-free Patients will be on a regimen of MMF, cyclosporine and steroids.	Drug: MMF, cyclosporine, steroids

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients who are recipients of primary or secondary renal allograft.
Patients who are single-organ recipients (kidney only).

Exclusion Criteria:

•Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228020

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Offner G, Toenshoff B, Höcker B, Krauss M, Bulla M, Cochat P, Fehrenbach H, Fischer W, Foulard M, Hoppe B, Hoyer PF, Jungraithmayr TC, Klaus G, Latta K, Leichter H, Mihatsch MJ, Misselwitz J, Montoya C, Müller-Wiefel DE, Neuhaus TJ, Pape L, Querfeld U, Plank C, Schwarke D, Wygoda S, Zimmerhackl LB. Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. Transplantation. 2008 Nov 15;86(9):1241-8.

Höcker B, Kovarik JM, Daniel V, Opelz G, Fehrenbach H, Holder M, Hoppe B, Hoyer P, Jungraithmayr TC, Köpf-Shakib S, Laube GF, Müller-Wiefel DE, Offner G, Plank C, Schröder M, Weber LT, Zimmerhackl LB, Tönshoff B. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation. 2008 Nov 15;86(9):1234-40.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00228020 History of Changes
Other Study ID Numbers:	CCHI621ADE01
Study First Received:	September 26, 2005
Last Updated:	August 24, 2010
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

pediatric, kidney transplantation, basiliximab

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Basiliximab
Antibodies, Monoclonal
Prednisone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on February 09, 2012