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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

Page last updated: August 23, 2015

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