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

Phase 4

Completed

• Conditions: Liver Transplantation; Kidney Transplantation; Heart Transplantation
• Interventions: Drug: Tacrolimus granules

• Registration Number: NCT01371331
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06-09
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2015-02-03
• Study Completion: 2015-02-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus granules	Tacrolimus granules	oral

Primary Outcome Measures

Name	Time	Method
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)	on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)	on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)	on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)	on Day 1 and Day 7 (+/- 7 days)

Secondary Outcome Measures

Name	Time	Method
Patient survival	14 days
Graft survival	14 days
Rejection episodes	14 days
Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs	14 days

Trial Locations

Locations (10)

Site 30; 🇩🇪 Heidelberg, Germany

Site 31; 🇩🇪 Hannover, Germany

Site: 60; 🇫🇷 Bron Cedex, France

Site 22; 🇪🇸 Madrid, Spain

Site 20; 🇪🇸 Madrid, Spain

Site 21; 🇪🇸 Madrid, Spain

Site 10; 🇬🇧 Birmingham, United Kingdom

Site 13; 🇬🇧 Manchester, United Kingdom

Site 40; 🇧🇪 Brussels, Belgium

Site 50; 🇵🇱 Warsaw, Poland