Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graf… (NCT07020832) | Clinical Trial Compass
SuspendedPhase 3
Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Stopped: Study temporarily suspended due to company acquisition and ongoing strategic evaluation of the program
Brazil320 participantsStarted 2026-05-18
Plain-language summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged at least 18 years
. Have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor.
. Be on dialysis at the time of your transplant and produce very little urine (less than 200 mL per day equivalent to ≤1 cup). You must have been on dialysis for at least 3 months.
. Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:
. It cannot be due to a serious infection or a serious blood clot in your previous transplant.
. Your calculated Panel Reactive Antibody (CPRA) level must be below 50%.
. Be getting a donor kidney that meets the study's specific requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — can you find out why it was suspended and whether that suspension raises any concerns about the safety or design of pegcetacoplan for kidney transplant patients like me?
2Since the main goal of this trial is measuring how quickly patients can get off dialysis within 90 days after transplant, how does that outcome compare to what I might expect with standard care after a deceased donor kidney transplant?
3Given that this is a Phase 3 trial specifically for people at high risk of delayed graft function, how would my transplant team determine whether I actually fall into that high-risk category, and does that change my treatment options?
4Because the trial is suspended and not actively enrolling, are there any other studies or approved treatments targeting delayed graft function that my care team is currently recommending instead?
5Pegcetacoplan works on the complement system — are there any known risks or safety signals from earlier phases of this drug's development in transplant patients that I should understand before considering it as an option in the future?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Be at low to medium risk of transplant rejection, and be scheduled to receive:
Exclusion criteria
. Have taken part in another medical research study or used an experimental drug, treatment, or device in the past 30 days (or longer, depending on the drug).
. Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs.
. Weigh less than 20kg or more than 120kg at screening.
. Have or had recently had any of the following infections:
. Hepatitis B or Hepatitis C (unless treated and no longer active).
. HIV (human immunodeficiency virus) at any time.
. Have had cancer in the past 5 years, unless it was:
. A small, treated skin cancer (like basal or squamous cell), or