Shift to Everolimus (RAD) Kidney Sparing Study
NCT00420537 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2010-01-12
Summary
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
Conditions
- Kidney Dysfunction
- Heart Transplantation
Interventions
- DRUG
-
cyclosporine
cyclosporine trough levels between 100 and 150
- DRUG
-
cyclosporine
cyclosporine trough levels between 40 and 90 ng/ml
- DRUG
-
Mycophenolate mofetil
mycophenolate with low doses
- DRUG
Sponsors & Collaborators
-
University of Bologna
lead OTHER
Principal Investigators
-
Angelo Branzi, MD · Alma Mater Studiorum University of Bologna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-01-31
- Completion
- 2009-03-31
Countries
- Italy
Study Locations
More Related Trials
-
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
NCT00154297 ·Status: COMPLETED ·Phase: PHASE4
-
Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up
NCT00596557 ·Status: COMPLETED ·Phase: PHASE4
-
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
NCT00154284 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
NCT00425308 ·Status: COMPLETED ·Phase: PHASE3
-
This is a 2-year Follow-up Study to Evaluate the Long-term Effects in Patients Who Completed the Study CRAD001A2307.
NCT00531440 ·Status: COMPLETED ·Phase: PHASE3
-
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
NCT00369161 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
NCT01544491 ·Status: COMPLETED ·Phase: PHASE3
-
Everolimus in de Novo Kidney Transplant Recipients
NCT01410448 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
NCT00154310 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004 ·Status: COMPLETED ·Phase: PHASE3
-
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
NCT04258423 ·Status: TERMINATED ·Phase: PHASE3
-
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
NCT01025817 ·Status: COMPLETED ·Phase: PHASE3
-
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
NCT00097968 ·Status: COMPLETED ·Phase: PHASE3
-
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
NCT00658320 ·Status: COMPLETED ·Phase: PHASE3
-
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
NCT01266148 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
NCT01455649 ·Status: UNKNOWN ·Phase: PHASE4
-
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
NCT01976390 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
NCT00820911 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
NCT00862979 ·Status: COMPLETED ·Phase: PHASE4
-
Renal Transplantation in the Elderly - nEverOld Study
NCT01631058 ·Status: UNKNOWN ·Phase: PHASE4
-
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
NCT01028092 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
NCT01354301 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
NCT00443937 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients
NCT00170833 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
NCT01608412 ·Status: UNKNOWN ·Phase: PHASE4