Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction
NCT01935128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2022-05-26
Summary
The purpose of this study is to evaluate whether conversion to everolimus (Zortress®), allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant) survival (measured by 2-3 year graft survival).
Conditions
- Renal Transplant
Interventions
- DRUG
-
Arm 1 Everolimus/Reduced dose tacrolimus
Immunosuppression drug intervention
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Toledo Health Science Campus
lead OTHER
Principal Investigators
-
Michael Rees, MD, PhD · University of Toledo, HSC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-03
- Primary Completion
- 2020-07-31
- Completion
- 2020-07-31
Countries
- United States
Study Locations
More Related Trials
-
Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium
NCT01680861 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
NCT00170820 ·Status: COMPLETED ·Phase: PHASE4
-
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
NCT00807144 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
NCT01598987 ·Status: COMPLETED ·Phase: PHASE3
-
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
NCT02736227 ·Status: COMPLETED ·Phase: NA
-
Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation
NCT03689075 ·Status: TERMINATED ·Phase: PHASE4
-
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT00903188 ·Status: UNKNOWN ·Phase: PHASE4
-
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
NCT00147381 ·Status: COMPLETED ·Phase: PHASE3
-
Differentiating Everolimus Versus Sirolimus in Combination With Calcineurin Inhibitors in Kidney Transplant Patients
NCT02062892 ·Status: WITHDRAWN ·Phase: PHASE4
-
Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus
NCT01038505 ·Status: WITHDRAWN ·Phase: PHASE4
-
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
NCT01936519 ·Status: COMPLETED ·Phase: NA
-
Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal
NCT00896012 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
NCT00407160 ·Status: COMPLETED
-
Effects of Zortress® + Tacrolimus vs. Standard Immunosuppression on Progression of Coronary Artery Calcifications and Bone Disease in de Novo Renal Transplant Recipients
NCT01612299 ·Status: WITHDRAWN ·Phase: NA
-
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
NCT03284242 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion
NCT00443508 ·Status: UNKNOWN ·Phase: PHASE4
-
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
NCT01028092 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
NCT00332839 ·Status: TERMINATED ·Phase: PHASE4
-
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
NCT01608412 ·Status: UNKNOWN ·Phase: PHASE4
-
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
NCT06280950 ·Status: RECRUITING ·Phase: PHASE2
-
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens
NCT01183247 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
NCT03978494 ·Status: WITHDRAWN ·Phase: PHASE1
-
Everolimus Monotherapy as Immunosuppression After Liver Transplant
NCT04063865 ·Status: TERMINATED ·Phase: PHASE3
-
Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients
NCT00170833 ·Status: COMPLETED ·Phase: PHASE3
-
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
NCT00170885 ·Status: COMPLETED ·Phase: PHASE4