A MULTICENTRE, RANDOMISED, OPEN CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF A COMBINATION OF TACROLIMUS AND MYCOPHENOLATE MOFETIL BASED REGIMEN WITH OR WITHOUT INDUCTION IN ELDERLY RECIPIENTS UNDERGOING KIDNEY TRANSPLANTATION - SENIOR (Safety and Efficacy with kNown Immunosuppression in Older Recipients)
- Conditions
- Patients with end stage kidney disease who will undergo primary renal transplantion or retransplantationMedDRA version: 7.0Level: LLTClassification code 10014646
- Registration Number
- EUCTR2004-000520-32-ES
- Lead Sponsor
- Fujisawa GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
1 Male or female patients minimum 60 years of age
2 Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
3. Patient is receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type
4. Patient has been fully informed and has given written informed consent according to ICH-GCP. 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 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) yes
F.1.3.1 Number of subjects for this age range
1. Patient has an immunological high risk, defined as a PRA grade >50%
2. Cold ischemia time of the donor kidney greater than 30 hours
3. Patient has significant liver disease, defined as having during the past 30 days continuously elevated ASAT (SGOT) and/or ALAT (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
4. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, basiliximab or to the excipients of the study medication
5. Patient requires ongoing dosing with corticosteroids
6. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.4 of protocol)
7. Patient or donor is known to be HIV positive
8. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
9. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
10. 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
11. Patient has previously received or is receiving an organ transplant other than kidney
12. Patient has been previously enrolled in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method