Pegcetacoplan to reduce delayed graft function after deceased-donor kidney transplant

A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

This will test whether pegcetacoplan can prevent delayed graft function in adults on dialysis who are receiving a deceased-donor kidney transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Apellis Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: rituximab, belimumab
• Locations: 1 site (São Paulo)
• Trial ID: NCT07020832 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, placebo-controlled study comparing pegcetacoplan to placebo in adults at high risk of delayed graft function after deceased-donor kidney transplantation. Participants receive pegcetacoplan or matching placebo around the time of transplant in addition to standard immunosuppression that includes ATG, corticosteroids, and tacrolimus. The study tracks rates of delayed graft function, early post-transplant kidney function, and safety events during the immediate post-transplant period. Enrollment is restricted to patients on dialysis with very low urine output who meet the study's donor and immunologic risk criteria.

Who should consider this trial

Good fit: Adults (≥18) with end-stage kidney disease on dialysis for at least 3 months who produce ≤200 mL urine per day and are scheduled to receive a qualifying deceased-donor kidney (first or select second transplants with CPRA <50) and planned to receive ATG, steroids, and tacrolimus.

Not a fit: Patients receiving a living-donor transplant, those not on dialysis or with higher urine output, those with high immunologic risk (CPRA ≥50) or disqualifying prior transplant complications, or those unable to receive the required immunosuppression are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, pegcetacoplan could reduce the chance of delayed graft function and improve early kidney function after transplant.

How similar studies have performed: Complement inhibition with pegcetacoplan has shown benefit in other complement-mediated diseases, but using it to prevent delayed graft function in kidney transplant is a novel application with limited prior clinical evidence.

Eligibility criteria

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.

Where this trial is running

São Paulo

• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Apellis Clinical Trial Information Line

Conditions Delayed Graft Function; End Stage Renal Disease; Deceased Donor Kidney Transplant