Clinical trial NCT07020832: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Delayed Graft Function
End Stage Renal Disease
Deceased Donor Kidney Transplant
Lead sponsor: Apellis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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). 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 if you're medically shown not to respond to them and your doctor has a plan to give you preventive antibiotics, with the sponsor's approval.

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.

Primary outcomes:
measure: Time to freedom from dialysis through Day 90
timeFrame: Duration of dialysis through day 90
Secondary outcomes:
measure: eGFR at Week 52
timeFrame: 52 weeks following surgery
measure: Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)
timeFrame: 7 days following surgery
measure: eGFR at Day 90
timeFrame: 90 days following surgery
measure: Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14
timeFrame: 14 days following surgery
measure: Biopsy-proven rejection-free kidney allograft survival by Week 52
timeFrame: 52 weeks following surgery
Other outcomes:
Locations:
Study officials:
References: