Kidney transplant Z94.0
Conditions
Interventions
Group 1: Prograf® (0.2mg/kg) + MMF + Corticosteroids (24 weeks)
Group 2: Advagraf® (0.2mg/kg) + MMF + Corticosteroids (24 weeks)
Group 3: Advagraf® (0.3mg/kg) + MMF + Corticosteroids (24 weeks)
Group
Sponsors
ASTELLAS Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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 month). 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).
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 Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest). 4.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 |
|---|---|
| The primary objective of this study is to compare the four therapy regimens with regard to efficacy failure rate. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Variables: - Renal function assessed by calculated GFR (Glomerular Filtration Rate) with MDRD formula at week 24 after transplantation - Renal function assessed by calculated creatinine clearance with Cockcroft and Gault formula at week 24 after transplantation - Acute rejection * Incidence of and time to first acute rejection * Incidence of and time to first corticosteroid-resistant acute rejection * Overall frequency of acute rejection episodes - Biopsy confirmed acute rejection * Incidence of and time to first biopsy confirmed acute rejection * Incidence of and time to first biopsy confirmed corticosteroid-resistant acute rejection * Overall frequency of biopsy confirmed acute rejection episodes * Severity of biopsy confirmed acute rejections (Banff `97 criteria) | — |
Countries
Austria, France, Germany, Italy, Netherlands, Spain
Contacts
Public ContactKaroline Röther
Universitätsklinikum Freiburg
Outcome results
None listed