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

This study is ongoing, but not recruiting participants.

First Received: September 26, 2005 Last Updated: July 21, 2008 History of Changes

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)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Study Start Date:

May 2001

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 National Clinical Trials Identifier (NCT ID):

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 ( Novartis )
Study ID Numbers:	CCHI621ADE01
Study First Received:	September 26, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00228020 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

pediatric, kidney transplantation, basiliximab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Prednisone
Cyclosporine
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Mycophenolic Acid
Enzyme Inhibitors

Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Basiliximab
Therapeutic Uses
Antifungal Agents
Mycophenolate mofetil
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010