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

• Conditions: Prophylaxis of heart, liver and kidney transplant rejection in paediatrics; MedDRA version: 18.0Level: LLTClassification code 10050434Term: Prophylaxis against liver transplant rejectionSystem Organ Class: 100000004865; MedDRA version: 18.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; MedDRA version: 18.0Level: LLTClassification code 10050432Term: Prophylaxis against heart transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-000078-80-GB
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

- The subject is aged < 16 years of age, undergoing primary liver, kidney or
heart allograft transplantation.
- The subject must be able to swallow intact Prograf® or Advagraf® capsules.
- Subjects, treated since transplantation with Basiliximab or ATG/ Mycophenolate
Mofetil (MMF)/steroids, whose gastric motility has resumed and whose renal function is adequate on Day 1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Subject is receiving a multi-organ transplant or has previously received an
organ transplant (including re-transplantation).
- Subject with pulmonary vascular resistance =4 Wood units despite medication.
- Subject with significant renal impairment, defined as having serum creatinine =230 µmol/l (=2.6 mg/dl) pre-transplantation. (Not applicable for renal transplanted subjects)
- Subject with significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels of =3 times the upper value of the normal range of the investigational site during the past 28 days. (Not applicable for liver transplanted subjects)
- Subject with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully. (Not applicable for
transplanted subjects with a primary organ diagnosis of cancer)
- Subject requiring systemic immunosuppressive medication for any other
indication than transplantation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified