New drug aims to wake up transplanted kidneys faster
NCT ID NCT07020832
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests a drug called pegcetacoplan in 320 adults who are getting a kidney transplant from a deceased donor and are at high risk for delayed graft function (when the kidney takes a while to start working). The goal is to see if the drug helps the kidney work sooner and reduces the need for dialysis after transplant. Participants will receive either pegcetacoplan or a placebo, and their kidney function will be tracked for up to a year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Started
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May 2026
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged at least 18 years 2. Have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor. 3. 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. 4. Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant: 1. It cannot be due to a serious infection or a serious blood clot in your previous transplant. 2. Your calculated Panel Reactive Antibody (CPRA) level must be below 50%. 5. Be getting a donor kidney that meets the study's specific requirements. 6. Be at low to medium risk of transplant rejection, and be scheduled to receive: 1. A medication called ATG as part of your transplant procedure. 2. Steroids (corticosteroids) as part of your treatment at the time of screening. 3. A medication called tacrolimus (or a similar drug) after your transplant, according to usual medical practice. 7. Have received certain vaccines before starting the study treatment, specifically: 1. Pneumococcal (S. pneumoniae) 2. Meningococcal (N. meningitidis types A, C, W, Y, and B) 3. Haemophilus influenzae type B If you haven't had these vaccines, you may still qualify to be part of the study, provided your doctor plans to administer preventive antibiotics until vaccination can be given per protocol, and with notification to the sponsor. Exclusion Criteria: 1. 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). 2. Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs. 3. Weigh less than 20kg or more than 120kg at screening. 4. Have or had recently had any of the following infections: 1. Hepatitis B or Hepatitis C (unless treated and no longer active). 2. HIV (human immunodeficiency virus) at any time. 5. Have had cancer in the past 5 years, unless it was: 1. A small, treated skin cancer (like basal or squamous cell), or 2. A very small kidney cancer that was found early and treated. 6. Have received any other organ transplant (except for one previous kidney transplant), or are scheduled for a transplant involving more than one organ.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 01323-001, Brazil
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Other studies related to the condition(s) this trial covers.
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