Status:
ACTIVE_NOT_RECRUITING
RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Radboud University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Renal Transplant Recipients
Elderly Patients
Eligibility:
All Genders
65-99 years
Phase:
PHASE4
Brief Summary
Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everol...
Detailed Description
In this study two immunosuppressive regimes will be tested; In both groups basiliximab induction will be applied. Additionally, the standard therapy consisting of prednisolone, mycophenolic acid and t...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed
- Male or female subject ≥65 years old
- Subject randomized within 24 hours of completion of transplant surgery
- 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
- 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
Exclusion
- Exclusion criteria for both stratum A and B
- Subject is a multi-organ transplant recipient
- Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
- Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity
- Recipient of a kidney with a cold ischaemia time (CIT) \>24 hr
- Recipients of a kidney from an HLA-identical related living donor
- Known intolerability for one or more of the study drugs
- Subject who is HIV positive
- 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
- 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)
- Subject with severe systemic infections, current or within the two weeks prior to randomization
- Subject with severe restrictive or obstructive pulmonary disorders
- Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
- Subject with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT03797196
Start Date
July 29 2019
End Date
December 1 2026
Last Update
May 10 2023
Active Locations (7)
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1
Leuven University Hospital
Leuven, Belgium
2
Amsterdam UMC
Amsterdam, Netherlands
3
UMCG
Groningen, Netherlands
4
LUMC
Leiden, Netherlands