A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
NCT01339468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-07-19
Summary
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
Conditions
- Liver Transplantation
Interventions
- DRUG
-
Advagraf
oral
- DRUG
-
Prograf
oral
- DRUG
-
Prograf
intravenous
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-27
- Primary Completion
- 2014-05-27
- Completion
- 2014-05-27
Countries
- South Korea
Study Locations
More Related Trials
-
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
-
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
-
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
NCT00909571 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
NCT02143479 ·Status: COMPLETED
-
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
NCT02057484 ·Status: COMPLETED
-
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
NCT01018914 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients
NCT00719745 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
NCT01294020 ·Status: COMPLETED ·Phase: PHASE2
-
Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation
NCT02105155 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
NCT01614665 ·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
-
Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion
NCT02882113 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
NCT00720265 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
NCT00282243 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
NCT00720408 ·Status: COMPLETED ·Phase: PHASE3
-
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
NCT01476488 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant
NCT03216447 ·Status: UNKNOWN ·Phase: PHASE4
-
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
-
Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)
NCT01744470 ·Status: UNKNOWN ·Phase: PHASE4
-
Pharmacokinetic Studies of Tacrolimus in Transplant Patients
NCT01889758 ·Status: COMPLETED ·Phase: PHASE4
-
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
NCT00384202 ·Status: COMPLETED ·Phase: PHASE3
-
Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)
NCT02154854 ·Status: UNKNOWN ·Phase: PHASE4
-
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
NCT03644485 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
NCT00608244 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
NCT02147938 ·Status: COMPLETED