Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
NCT ID: NCT00228020
Last Updated: 2010-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
212 participants
INTERVENTIONAL
2001-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides
NCT00001473
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
NCT05495893
Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome
NCT04402580
Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis
NCT05101447
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
NCT00987389
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Basiliximab
Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
Basiliximab-free
Patients will be on a regimen of MMF, cyclosporine and steroids.
MMF, cyclosporine, steroids
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
MMF, cyclosporine, steroids
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who are single-organ recipients (kidney only).
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis
Role: STUDY_DIRECTOR
Novartis
References
Explore related publications, articles, or registry entries linked to this study.
Offner G, Toenshoff B, Hocker 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, Muller-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. doi: 10.1097/TP.0b013e318188af15.
Hocker B, Kovarik JM, Daniel V, Opelz G, Fehrenbach H, Holder M, Hoppe B, Hoyer P, Jungraithmayr TC, Kopf-Shakib S, Laube GF, Muller-Wiefel DE, Offner G, Plank C, Schroder M, Weber LT, Zimmerhackl LB, Tonshoff B. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation. 2008 Nov 15;86(9):1234-40. doi: 10.1097/TP.0b013e318188ae18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCHI621ADE01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.