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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00369161 |
This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.
Condition | Intervention | Phase |
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Renal Transplantation |
Drug: Everolimus (RAD001) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Twelve-Month, Multicenter, Open-Label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With IL-2 Receptor Antagonist, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients |
Estimated Enrollment: | 230 |
Study Start Date: | June 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Patient with any severe allergy requiring acute (within 4 weeks of baseline) * chronic treatment or
Responsible Party: | Novartis Pharmaceticals ( External Affairs ) |
Study ID Numbers: | CRAD001A2426 |
Study First Received: | August 25, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00369161 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Everolimus Immunologic Factors Tacrolimus Immunosuppressive Agents |
Everolimus Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |