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

Phase 3

Not yet recruiting

• Conditions: Delayed Graft Function; Deceased Donor Kidney Transplant; End Stage Renal Disease
• Interventions: Drug: Pegcetacoplan; Other: Placebo

• Registration Number: NCT07020832
• Lead Sponsor: Apellis Pharmaceuticals, Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-09
• Primary Completion: 2027-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegceptacoplan	Pegcetacoplan	Administration as a 20mL IV infusion initially, then as a subcutaneous infusion
Placebo	Placebo	Administration as a 20mL IV infusion initially, then as a subcutaneous infusion

Primary Outcome Measures

Name	Time	Method
Time to freedom from dialysis through Day 90	Duration of dialysis through day 90	To assess the efficacy of pegcetacoplan compared with that of placebo in participants at high risk of DGF following donor kidney allograft transplant surgery

Secondary Outcome Measures

Name	Time	Method
eGFR at Week 52	52 weeks following surgery	To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes
Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)	7 days following surgery	To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes
eGFR at Day 90	90 days following surgery	To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes
Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14	14 days following surgery	To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes
Biopsy-proven rejection-free kidney allograft survival by Week 52	52 weeks following surgery	To evaluate the efficacy of pegcetacoplan in reducing the severity of DGF and consequent improvements in short-, medium- and long-term kidney function and kidney allograph outcomes