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NCT01332201 Clinical Trial

Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

Lung Transplantation Clinical Trial

Official title:
A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332201
Other study ID # PMR-EC-1501
Secondary ID 2010-019859-21
Status Completed
Phase Phase 2
First received April 7, 2011
Last updated June 12, 2015
Start date July 2011
Est. completion date November 2013

Study information
Verified date June 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: National Institute of HealthTaiwan : Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)

- negative pregnancy test prior to enrolment (females)

- agree to practice effective birth control during the study

- treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1

Exclusion Criteria:

- receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)

- pulmonary vascular resistance =4 Wood units despite medication

- required an emergency ventricular assist device within one week prior to transplantation

- significant renal impairment

- significant liver disease

- malignancies or a history of malignancy within the last 5 years

- significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer

- requires systemic immunosuppressive medication for any other indication than transplantation

- diagnosis of cystic fibrosis

- pregnant or breast-feeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Advagraf
oral
• Prograf
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Italy,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary determine steady state systemic exposure (AUC 0-24h) Day 1, Day 3, Day 7 and Day 42 No
Secondary determine Cmax (maximum concentration) Day 1, Day 3, Day 7 and Day 42 No
Secondary determine tmax (time to attain Cmax) Day 1, Day 3, Day 7 and Day 42 No
Secondary determine C24 (concentration prior to next morning dose) Day 1, Day 3, Day 7 and Day 42 No
Secondary describe rejection episodes up to 58 weeks No
Secondary describe subject survival up to 58 weeks No
Secondary describe graft survival up to 58 weeks No
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Terminated NCT00235651 - Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients Phase 3
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