A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant
Description
Brief Summary
The purpose of this trial is to evaluate the reduction in incidence and severity of delayed
graft function with kidney allografts from donors >45 years after brain death (DBD).
Detailed Description
This is a Phase 3 randomized, placebo-controlled, double-blind, multi-center trial stratified
by donor age and by region to evaluate the reduction in incidence and severity of delayed
graft function with kidney allografts from DBD donors who were at least 45 years of age.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- Has the ability to understand the requirements of the study, is able to provide written informed consent and is willing and able to comply with the requirements of the study protocol.
- Male or female at least 18 years of age.
- Has dialysis dependent renal failure initiated at least 2 months prior to transplantation.
- Is to be a recipient of a transplant from a deceased donor (brain death criteria) ≥ 45 years of age.
- Based on donor age, the following requirements for the risk of DGF (determined using the Irish DGF risk assessment nomogram) and cold ischemia time (CIT) must be met:
- Donor age 45
- 59 years: estimated DGF risk ≥ 20% and estimated CIT ≥ 10 hour
- Donor age ≥ 60 years: no minimum estimated DGF risk or minimum estimated CIT
- Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.
- Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
- Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
- Recipient of donor kidney preserved with normothermic machine perfusion.
- Scheduled to undergo multiorgan transplantation.
- Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- Has lost first kidney transplant due to graft thrombosis.
- Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
- Is scheduled to receive an ABO-incompatible donor kidney.
- Has a positive T
- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC crossmatch method, if performed.
- Has a positive T
- or B-cell flow cross-match AND donor specific anti-HLA antibody (DSA) detected by flow cytometry, Luminex
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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