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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01371331
First received: June 9, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Kidney Transplantation
Heart Transplantation
Drug: Tacrolimus granules
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Determine AUCtau (area under the plasma concentration-time curve for a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
  • Determine Cmax (maximum concentration) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
  • Determine tmax (time to attain Cmax) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
  • Determine Ctrough (plasma concentration at the end of a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rejection episodes [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Graft survival [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus granules Drug: Tacrolimus granules
oral
Other Name: Modigraf

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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371331

Contacts
Contact: Medical Affairs Europe + 44 20 3379 8000 contact@nl.astellas.com

Locations
Belgium
Site 40 Completed
Brussels, Belgium, 1200
Site: 41 Withdrawn
Leuven, Belgium, 3000
France
Site: 60 Not yet recruiting
Bron Cedex, France, 69677
Site: 61 Not yet recruiting
Paris Cedex, France, 75935
Germany
Site 31 Active, not recruiting
Hannover, Germany, 30625
Site 30 Recruiting
Heidelberg, Germany, 69120
Poland
Site 50 Suspended
Warsaw, Poland, 04-730
Spain
Site 21 Recruiting
Madrid, Spain, 28046
Site 20 Active, not recruiting
Madrid, Spain, 28046
Site 22 Recruiting
Madrid, Spain, 28007
United Kingdom
Site 10 Terminated
Birmingham, United Kingdom, B4 6NH
Site 11 Withdrawn
London, United Kingdom, WC1N3JH
Site 13 Recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Senior Study Manager Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01371331     History of Changes
Other Study ID Numbers: F506-CL-0403, 2009-012258-19
Study First Received: June 9, 2011
Last Updated: August 13, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Ministry of Health
Spain: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Liver Transplantation
Heart Transplantation
Pharmacokinetics

Additional relevant MeSH terms:
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014