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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01332201

Enrollment

Registered

2011-04-11

Start date

2011-07-31

Completion date

2013-11-30

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation

Keywords

Advagraf, Heart, Lung, Pancreas, Transplant, Immunosuppression, Pharmacokinetics

Brief 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.

Interventions

DRUGAdvagraf

oral

DRUGPrograf

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
determine steady state systemic exposure (AUC 0-24h)	Day 1, Day 3, Day 7 and Day 42

Secondary

Measure	Time frame
determine tmax (time to attain Cmax)	Day 1, Day 3, Day 7 and Day 42
determine C24 (concentration prior to next morning dose)	Day 1, Day 3, Day 7 and Day 42
determine Cmax (maximum concentration)	Day 1, Day 3, Day 7 and Day 42
describe subject survival	up to 58 weeks
describe graft survival	up to 58 weeks
describe rejection episodes	up to 58 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026