Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
NCT03603548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2018-07-27
Summary
Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
Conditions
- Liver Transplant Rejection
- Immunosuppression
Interventions
- DRUG
-
Envarsus
Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
- DRUG
-
Advagraf
Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
Sponsors & Collaborators
-
Medical University of Warsaw
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-09
- Primary Completion
- 2023-07-09
- Completion
- 2023-07-09
Countries
- Poland
Study Locations
More Related Trials
-
Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients
NCT05655273 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE4
-
Evaluate the Efficacy and Safety of the ADVAGRAF®
NCT04763096 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
NCT03386305 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
NCT01339468 ·Status: COMPLETED ·Phase: PHASE4
-
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
NCT03289650 ·Status: COMPLETED ·Phase: PHASE3
-
Extended-Release Tacrolimus Following Liver Transplantation
NCT05242315 ·Status: RECRUITING ·Phase: PHASE4
-
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
NCT02143479 ·Status: COMPLETED
-
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
NCT01882322 ·Status: COMPLETED ·Phase: PHASE4
-
Envarsus Neurotoxicity Burden in Liver Transplant Patients
NCT03823768 ·Status: COMPLETED ·Phase: PHASE4
-
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
NCT06268769 ·Status: RECRUITING ·Phase: PHASE4
-
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
NCT03373227 ·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
-
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
NCT03511560 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
NCT04225988 ·Status: COMPLETED ·Phase: PHASE4
-
Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients
NCT03438773 ·Status: UNKNOWN ·Phase: PHASE1
-
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
-
Early Use of Long-acting Tacrolimus in Lung Transplant Recipients
NCT04469842 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Envarsus XR Compared to Immediate Release Tacrolimus
NCT03979365 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
NCT01332201 ·Status: COMPLETED ·Phase: PHASE2
-
PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®)
NCT02882828 ·Status: COMPLETED ·Phase: PHASE4
-
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
NCT04761731 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
NCT01018914 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients
NCT02500212 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
NCT01551212 ·Status: COMPLETED ·Phase: PHASE4
-
Everolimus Monotherapy as Immunosuppression After Liver Transplant
NCT04063865 ·Status: TERMINATED ·Phase: PHASE3