Study comparing standard immunosuppression with a combination of immunosuppressive agents in patients receiving a renal transplant, in elderly patients.
- Conditions
- de novo renal transplantation in elderly patients.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-003194-10-NL
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 374
4.2 Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed
2. Male or female subject =65 years old
3. Subject randomized within 24 hours of completion of transplant surgery
4. Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older
5. Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 374
4.3 Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study
Exclusion criteria for both stratum A and B
1. Subject is a multi-organ transplant recipient
2. Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
3. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity
4. Recipient of a kidney with a cold ischaemia time (CIT) >24 hr
5. Recipients of a kidney from an HLA-identical related living donor
6. Known intolerability for one or more of the study drugs
7. Subject who is HIV positive
8. HBsAg and/or a HCV positive subject with evidence of elevated liver function tests (ALT/AST levels =2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable
9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus
(HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV)
10. Subject with a BMI greater than 35 kg/m2
11. Subject with severe systemic infections, current or within the two weeks prior to
randomization
12. Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy
13. History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
14. Subject with severe restrictive or obstructive pulmonary disorders
15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
16. Subject with white blood cell (WBC) count = 2,000/mm3 or with platelet count = 50,000/mm3
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