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

Astellas

Status and phase: Completed; Phase 2

Conditions: Lung Transplantation; Pancreas (Including SPK) Transplantation; Heart Transplantation

Treatments: Drug: Prograf; Drug: Advagraf

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332201

2010-019859-21 (EudraCT Number)

PMR-EC-1501

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Advagraf

Experimental group

Treatment:

Drug: Advagraf

Prograf

Active Comparator group

Treatment:

Drug: Prograf