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

Kidney Transplantation Clinical Trial

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Official title:

A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371331
• Other study ID #: F506-CL-0403
• Secondary ID: 2009-012258-19
• Status: Completed
• Phase: Phase 4
• Start date: June 9, 2011
• Est. completion date: February 3, 2015

Study information

• Verified date: August 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 3, 2015
• Est. primary completion date: February 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation
• Kidney Transplantation
• Liver Transplantation

Intervention

Drug:
• Tacrolimus granules
oral

Locations

Country	Name	City	State
Belgium	Site 40	Brussels
France	Site: 60	Bron Cedex
Germany	Site 31	Hannover
Germany	Site 30	Heidelberg
Poland	Site 50	Warsaw
Spain	Site 20	Madrid
Spain	Site 21	Madrid
Spain	Site 22	Madrid
United Kingdom	Site 10	Birmingham
United Kingdom	Site 13	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)		on Day 1 and Day 7 (+/- 7 days)
Primary	Determine Cmax (maximum concentration)		on Day 1 and Day 7 (+/- 7 days)
Primary	Determine tmax (time to attain Cmax)		on Day 1 and Day 7 (+/- 7 days)
Primary	Determine Ctrough (plasma concentration at the end of a dosing interval)		on Day 1 and Day 7 (+/- 7 days)
Secondary	Rejection episodes		14 days
Secondary	Patient survival		14 days
Secondary	Graft survival		14 days
Secondary	Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs		14 days

External Links

•   Link to results on Astellas Clinical Study Results website