A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION THERAPY OF TACROLIMUS WITH SIROLIMUS VERSUS TACROLIMUS WITH MYCOPHENOLATE MOFETIL IN KIDNEY TRANSPLANTATION - RESTORE(Regimen Evaluation Study with Tacrolimus Observing Renal Efficacy)
- Conditions
- Patients with end stage kidney disease who will undergo primary renal transplantation or retransplantation.MedDRA version: 7.0Level: LLTClassification code 10014646
- Registration Number
- EUCTR2004-000457-34-AT
- Lead Sponsor
- Fujisawa GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1.Male or female patients between 18 and 60 years of age.
2.Female patient of childbearing potential agrees to maintain effective birth control during the study and 3 months thereafter.
3.Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation (unless the graft was lost from rejection within 12 months).
4.Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor with compatible AB0 blood type.
5.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
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) no
F.1.3.1 Number of subjects for this age range
1. Patient has a high immunological risk, defined as a PRA grade >50% in the previous 6 months and / or having a previous graft survival < 1 year due to immunological reason.
2. Patient is receiving a graft from a non-heart-beating donor.
3. Cold ischemia time of the donor kidney greater than 30 hours.
4. Patient has significant liver disease, defined as having during the past 30 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 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. Patient has severe hypercholesterolaemia (cholesterol >350mg/dL, 9.1 mmol/dL). Patient with controlled hyperlipidemia is acceptable.
6. Patient is pregnant or breastfeeding.
7. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, sirolimus or to the excipients of the study medication.
8. Patient requires ongoing dosing with corticosteroids.
9. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.6).
10. Patient or donor is known to be HIV positive.
11. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
12. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
13. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days.
14. Patient has previously received or is receiving an organ transplant other than kidney.
15. Patient has been previously enrolled in this study.
16. Patient is unlikely to comply with the visits scheduled in the protocol.
17. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective of this study is to compare the two therapy regimens (Arm 1: tacrolimus + sirolimus + corticosteroids, Arm 2: tacrolimus + MMF + corticosteroids)with regard to renal function by using calculated creatinine clearance. The aim is to demonstrate that Arm 1 is non-inferior to Arm 2 with regard to the primary endpoint.;Secondary Objective: The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens (Arm 1: tacrolimus + sirolimus + corticosteroids, Arm 2 : tacrolimus + MMF + corticosteroids);Primary end point(s): The primary efficacy endpoint of this study will be the renal function measured by calculated creatinine clearance at month 6 (by using the Cockcroft formula).<br>
- Secondary Outcome Measures
Name Time Method