Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01294020
First received: February 3, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Conversion of stable pediatric allograft recipients from Prograf immunosuppression to Advagraf immunosuppression to compare exposure and follow for safety and efficacy over one year.


Condition Intervention Phase
Kidney Transplantation
Liver Transplantation
Heart Transplantation
Lung Transplantation
Intestine Transplantation
Drug: Advagraf
Drug: Prograf
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • determine steady state systemic exposure (AUC0-24h) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine Cmax (maximum concentration) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • determine tmax (time to attain Cmax) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • determine C24 (concentration prior to morning dose) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • rejection episodes [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • subject survival [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • graft survival [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: May 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conversion from Prograf to Advagraf Drug: Advagraf
Oral
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release
Drug: Prograf
Oral
Other Names:
  • FK506
  • tacrolimus

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01294020

Contacts
Contact: Medical Affairs Europe + 44 1784 419400 contact@nl.astellas.com

Locations
Austria
Site: 11 Not yet recruiting
Vienna, Austria, 1090
Belgium
Site: 21 Not yet recruiting
Brussels, Belgium, 1020
Site: 22 Recruiting
Brussels, Belgium, 1020
Czech Republic
Site: 42 Not yet recruiting
Prague, Czech Republic
France
Site: 34 Recruiting
Bron, France, 69677
Site: 33 Withdrawn
Paris, France, 75015
Site: 31 Recruiting
Paris, France, 75743
Site: 32 Recruiting
Paris, France, 75743
Germany
Site: 41 Recruiting
Heidelberg, Germany, 69115
Italy
Site: 39003 Not yet recruiting
Bergamo, Italy, 24127
Site: 39004 Not yet recruiting
Padova, Italy, 35128
Site: 39005 Not yet recruiting
Palermo, Italy, 90127
Site: 39002 Not yet recruiting
Rome, Italy, 165
Site: 39001 Not yet recruiting
Rome, Italy, 165
Poland
Site: 51 Recruiting
Warsaw, Poland, 04-730
Site: 52 Recruiting
Warsaw, Poland, 04-730
United Kingdom
Site: 61 Recruiting
Birmingham, United Kingdom, B4 6NH
Site: 62 Recruiting
Manchester, United Kingdom, M27 4HA
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01294020     History of Changes
Other Study ID Numbers: PMR-EC-1206, 2010-020925-42
Study First Received: February 3, 2011
Last Updated: March 12, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Advagraf
Liver
Kidney
Heart
Lung
Transplant
Immunosuppression
Pharmacokinetics

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

ClinicalTrials.gov processed this record on July 28, 2014