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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371331
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Heart Transplantation Liver Transplantation Drug: Tacrolimus granules Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
Study Start Date : June 2011
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tacrolimus granules
Drug: Tacrolimus granules
Other Name: Modigraf

Outcome Measures

Primary Outcome Measures :
  1. Determine AUCtau (area under the plasma concentration-time curve for a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ]
  2. Determine Cmax (maximum concentration) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ]
  3. Determine tmax (time to attain Cmax) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ]
  4. Determine Ctrough (plasma concentration at the end of a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ]

Secondary Outcome Measures :
  1. Rejection episodes [ Time Frame: 14 days ]
  2. Patient survival [ Time Frame: 14 days ]
  3. Graft survival [ Time Frame: 14 days ]
  4. Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371331

Site 40
Brussels, Belgium, 1200
Site: 60
Bron Cedex, France, 69677
Site 31
Hannover, Germany, 30625
Site 30
Heidelberg, Germany, 69120
Site 50
Warsaw, Poland, 04-730
Site 22
Madrid, Spain, 28007
Site 20
Madrid, Spain, 28046
Site 21
Madrid, Spain, 28046
United Kingdom
Site 10
Birmingham, United Kingdom, B4 6NH
Site 13
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Study Chair: Senior Study Manager Astellas Pharma Europe Ltd.
More Information

Additional Information:
Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT01371331     History of Changes
Other Study ID Numbers: F506-CL-0403
2009-012258-19 ( EudraCT Number )
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Kidney Transplantation
Heart Transplantation
Liver Transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action