Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation; Liver Transplantation; Heart Transplantation; Lung Transplantation; Intestine Transplantation
Intervention: Advagraf (Drug); Prograf (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Astellas Pharma Europe Ltd. Official(s) and/or principal investigator(s): Use Central Contact, Study Chair, Affiliation: Astellas Pharma Europe Ltd.
Overall contact: Medical Affairs Europe, Phone: + 44 1784 419400, Email: Astellas.registration@astellas.com
Summary
Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to
Advagraf® immunosuppression to compare exposure and follow for safety and efficacy over one
year.
Clinical Details
Official title: A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: determine steady state systemic exposure (AUC0-24h)
Secondary outcome: determine Cmax (maximum concentration)determine tmax (time to attain Cmax) determine C24 (concentration prior to morning dose) rejection episodes subject survival graft survival assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs
Detailed description:
Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have
completed Part B and to whom continued treatment with Advagraf® is not currently available,
will be offered participation in a continuation of long-term follow-up Part C. Part C will
continue until Advagraf® becomes available to these patients or these patients'
discontinuation, whichever is the earliest.
This applies to patients in the following countries: Czech Republic, Germany, Italy and
Poland only.
Eligibility
Minimum age: 5 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must be able to swallow intact study medication capsules
- Received a single solid organ transplant at least 6 months prior to entry into the
study
- The subject's parent(s), or their legal representative(s), has been fully informed
and has given written informed consent to participate in the study. The subject has
given assent where applicable
- Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3
months
- Negative pregnancy test prior to enrolment (females)
- Must agree to practice effective birth control during the study
- Stable whole blood trough levels of tacrolimus in the range of 3. 5 - 15ng/mL
(+/-0. 5ng/mL) and clinically stable in the opinion of the Investigator
Exclusion Criteria:
- Previously received a multiple organ transplant
- Any rejection episode within 3 months prior to enrolment or within the last 6 months
that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes
within the last 12 months
- Currently receiving Rapamycin, Certican or MPA (Myfortic®)
- Chronic dysfunction of the allograft, in the opinion of the Investigator
- Major changes in their immunosuppressive regimen within the last 3 months prior to
entry into the study
- The subject is pregnant or breast feeding
Locations and Contacts
Medical Affairs Europe, Phone: + 44 1784 419400, Email: Astellas.registration@astellas.com
Site: 11, Vienna 1090, Austria; Completed
Site: 21, Brussels 1020, Belgium; Completed
Site: 22, Brussels 1020, Belgium; Recruiting
Site: 42, Prague, Czech Republic; Recruiting
Site: 35 Hopital Femme Mere Enfant, BRON Cedex, France; Recruiting
Site: 34, Bron 69677, France; Recruiting
Site: 31, Paris 75743, France; Recruiting
Site: 32, Paris 75743, France; Recruiting
Site: 33, Paris 75015, France; Completed
Site: 41, Heidelberg 69115, Germany; Recruiting
Site: 74, Bergamo 25127, Italy; Recruiting
Site: 73, Padova 35128, Italy; Not yet recruiting
Site: 75, Palermo 90127, Italy; Recruiting
Site: 71, Rome 00165, Italy; Not yet recruiting
Site: 72, Rome 165, Italy; Not yet recruiting
Site: 51, Warsaw 04-730, Poland; Recruiting
Site: 52, Warsaw 04-730, Poland; Recruiting
Site: 61, Birmingham B4 6NH, United Kingdom; Recruiting
Site: 64 Great Ormond Street Hospital, London, United Kingdom; Recruiting
Site: 62, Manchester M27 4HA, United Kingdom; Recruiting
Additional Information
Starting date: May 2011
Last updated: July 21, 2015
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