Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

NCT01294020

Intestine Transplantation Kidney Transplantation Lung Transplantation +2 more

COMPLETED PHASE2

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

NCT01339468

Liver Transplantation

COMPLETED 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

Heart Transplantation Kidney Transplantation Liver Transplantation

COMPLETED PHASE2

Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation

NCT01742624

de Novo Kidney Transplantation

COMPLETED PHASE4

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

NCT02057484

Liver Transplant Kidney Transplant

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Transplantation Lung Transplantation Pancreas (Including SPK) Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Advagraf

Group Type EXPERIMENTAL

Advagraf

Intervention Type DRUG

oral

Prograf

Group Type ACTIVE_COMPARATOR

Prograf

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Advagraf

oral

Intervention Type DRUG

Prograf

oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FK506E MR4 tacrolimus modified release tacrolimus FK506

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
* negative pregnancy test prior to enrolment (females)
* agree to practice effective birth control during the study
* treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (\<230 µmol/l (\<2.6 ml/dl)) on Day 1

Exclusion Criteria

* receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
* pulmonary vascular resistance ≥4 Wood units despite medication
* required an emergency ventricular assist device within one week prior to transplantation
* significant renal impairment
* significant liver disease
* malignancies or a history of malignancy within the last 5 years
* significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
* requires systemic immunosuppressive medication for any other indication than transplantation
* diagnosis of cystic fibrosis
* pregnant or breast-feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No