Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
NCT07033858 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-06-24
Summary
Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®/Astagraf XL®, Astellas company).
Conditions
- Kidney Transplant; Complications
Interventions
- DRUG
-
Rapamune Pill
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
Sponsors & Collaborators
-
Shahid Beheshti University of Medical Sciences
lead OTHER
Principal Investigators
-
Dalili · SBMU
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2026-03-01
- Completion
- 2026-07-01
Countries
- Iran
Study Locations
More Related Trials
-
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
NCT00123331 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
NCT01294020 ·Status: COMPLETED ·Phase: PHASE2
-
A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients
NCT01742676 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation
NCT00811915 ·Status: TERMINATED ·Phase: PHASE3
-
Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk
NCT01702207 ·Status: COMPLETED ·Phase: PHASE4
-
European Transplant Registry of Senior Renal Transplant Recipients on Advagraf
NCT02558452 ·Status: NOT_YET_RECRUITING
-
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
NCT01332201 ·Status: COMPLETED ·Phase: PHASE2
-
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
NCT02057484 ·Status: COMPLETED
-
Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
NCT01742624 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)
NCT01744470 ·Status: UNKNOWN ·Phase: PHASE4
-
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
NCT01680952 ·Status: COMPLETED ·Phase: PHASE4
-
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
NCT00306397 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
NCT01839929 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
NCT00273871 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
NCT02034747 ·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
-
Study Evaluating Rapamune in Patients After Kidney Transplantation
NCT00240214 ·Status: TERMINATED
-
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
NCT00807144 ·Status: COMPLETED ·Phase: PHASE4
-
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
NCT00637143 ·Status: COMPLETED ·Phase: PHASE4
-
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
NCT03194321 ·Status: COMPLETED ·Phase: PHASE4
-
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
NCT02555787 ·Status: COMPLETED
-
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
NCT00282568 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
NCT00866879 ·Status: COMPLETED ·Phase: PHASE4
-
Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus
NCT02805842 ·Status: UNKNOWN ·Phase: PHASE3
-
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
NCT00248313 ·Status: COMPLETED ·Phase: PHASE3