Prophylaxis of rejection in kidney allograft recipients (via immunosuppression) MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Trade Name: Prograf capsules
Product Name: Tacrolimus capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is eligible for the study if all of the following apply: 1. Age = 18 years. 2. End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months). 3. Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type. 4. Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. 5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject will be excluded from participation if any of the following apply: 1. Receiving or having previously received an organ transplant other than a kidney. 2. Cold ischemia time of the donor kidney > 30 hours. 3. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest). 4. Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels = 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor. 5. Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s). 6. Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation. 7. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. 8. Pregnant woman or breast-feeding mother. 9. Subject or donor known to be HIV positive. 10. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients. 11. Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. 12. Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment. 13. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. 14. Unlikely to comply with the visits scheduled in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the four therapy regimens with regard to efficacy failure rate.;Secondary Objective: The secondary objective is to compare the efficacy and safety profiles of the four therapy regimens with each other. Efficacy failure rate will be assessed using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection (BCAR) and graft dysfunction.;Primary end point(s): The primary analysis of this study is to demonstrate the non-inferiority of the three Advagraf® Arms vs. the Prograf® Arm 24 weeks after renal transplantation with regard to efficacy failure rate using a composite endpoint consisting of any of the following: a) graft loss (defined as re-transplantation, nephrectomy, death or as dialysis ongoing at study end or at time of discontinuation of the subject from the study unless superseded by follow-up information) b) biopsy confirmed acute rejection (BCAR); c) graft dysfunction (defined as glomerular filtration rate (GFR) < 40 mL/min/1.73m2 estimated by MDRD formula 24 weeks after transplantation). The primary composite endpoint of the study is the incidence of and time to first incidence of graft loss or BCAR or graft dysfunction. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed