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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Liver Transplantation
  • Kidney Transplantation
  • Heart Transplantation
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01371331
Primary Trial ID Number
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.
Research Details
  • 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.
Phase
Phase 4
Study Design
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Study Type
Interventional
Intervention
Drug : Tacrolimus granules

Study Arm Groups : Tacrolimus granules

Intervention Type
See Interventions above
Primary Outcome Measures
  • Determine AUCtau (area under the plasma concentration-time curve for a dosing interval); on Day 1 and Day 7 (+/- 7 days); Determine Cmax (maximum concentration); 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)
Secondary Outcome Measures
  • Rejection episodes; 14 days; Patient survival; 14 days; Graft survival; 14 days; Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs; 14 days
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - 12 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Birmingham
West Midlands
B4 6NH
Manchester Royal Infirmary
Manchester
England
M13 9WL
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, France, Germany, Poland, Spain, United Kingdom
Scientific Title
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
F506-CL-0403
Sponsor(s)
Astellas Pharma Europe Ltd.
Key Dates

Recruitment Start Date

Jun 2011

Recruitment End Date

Feb 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 Jun 2011

Last Updated

22 May 2015