A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation

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

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-09

Study Completion Date

2015-02-03

Brief Summary

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

The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.

Related Clinical Trials

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

A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

NCT05152628

Liver Transplantation Kidney Transplantation

COMPLETED PHASE4

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

NCT01371344

Heart Transplantation Kidney Transplantation Liver Transplantation

TERMINATED PHASE4

A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

NCT05153915

Liver Transplantation Kidney 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

Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients

NCT02337036

Liver Transplantation, Child

UNKNOWN NA

Detailed Description

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

The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.

Conditions

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

Kidney Transplantation Heart Transplantation Liver Transplantation

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Tacrolimus granules

oral

Group Type EXPERIMENTAL

Tacrolimus granules

Intervention Type DRUG

oral

Interventions

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

Tacrolimus granules

oral

Intervention Type DRUG

Other Intervention Names

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

Modigraf

Eligibility Criteria

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

Inclusion Criteria

* The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart

Exclusion Criteria

* The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation)
* Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA) score \>50% in the previous 6 months (only applicable for renal transplant recipients)
* Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients)
* Subject receives an AB0 incompatible donor organ
* Subject has significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients)
* Subject has significant liver disease, defined as having elevated Alanine Aminotransferase (ALT) and/or Asparate Aminotransferase (AST) and/or Total Bilirubin levels 3 times the upper value of the normal range during the 28 days prior to transplantation (not applicable for liver transplant recipients)
* Subject with pulmonary vascular resistance greater than 4 Wood units which is unresponsive to treatment
* Subjects with malignancies or a history of malignancy within the last 5 years
* Subject has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer
* Subject requires systemic immunosuppressive medication for any indication other than transplantation
* Recipient or donor known to be HIV, HCV or HBV positive
* Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus
* Subject is currently participating in another clinical trial and/or has been taking an investigational drug in the 3 months prior to transplantation
* Subject is unlikely to comply with the visits scheduled in the protocol
* Subjects taking or requiring to be treated with medication or substances prohibited by this protocol

Minimum Eligible Age

0 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No