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Clinical Trials in Belgium / NCT03797196
Active, not recruiting Phase 4

RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

NCT03797196 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 4
Started
2019-07-29
Last updated
2023-05-10

Condition(s) studied

Renal Transplant RecipientsElderly PatientsImmunosuppression

Investigational drug(s) / intervention(s)

low dose tacrolimus in combination with everolimusAll Tacrolimus trials (41) →All Everolimus trials (53) →standard dose tacrolimus with mycophenolate mofetil

low dose tacrolimus in combination with everolimus: a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

standard dose tacrolimus with mycophenolate mofetil: A standard Tacrolimus once-daily (Envarsus) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

Study summary

Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus.

The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (\>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (\<65 years).

Eligibility

Sex
ALL
Min age
65 Years
Max age
99 Years
Healthy volunteers
No
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 Exclusion Criteria: 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 severe systemic infections, current or within the two weeks prior to randomization 11. Subject with severe restrictive or obstructive pulmonary disorders 12. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled 13. Subject with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Leuven University Hospital Leuven Belgium
Amsterdam UMC Amsterdam Netherlands
UMCG Groningen Netherlands
LUMC Leiden Netherlands
Radboud University Hospital Nijmegen Netherlands
Erasmus MC Rotterdam Netherlands
UMCU Utrecht Netherlands

More University Medical Center Groningen trials in Belgium

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03797196 on ClinicalTrials.gov ↗ ← All trials in Belgium