BridgeMD
OPTIMIZE
EU CTIS ID: 2024-516509-22-00
What this study is testing
The overall primary study endpoint “successful transplantation” as defined for the individual strata and analyzed for the whole study population. Stratum A: Primary endpoint: successful transplantation at two years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min/1.73m2. Stratum B: Primary endpoint: successful transplantation at two years after transplantation defined as absence of graft or patient loss in the presence of an eGFR above 45 ml/min/1.73m2.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Subject is a multi-organ transplant recipient
- 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
- Recipient of bloodgroup ABO incompatible allograft or CDC cross-match positive transplant
See the full eligibility criteria
- 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
- Subject is a multi-organ transplant recipient
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.