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

Apellis Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Other: Placebo; Drug: Pegcetacoplan

Study type: Interventional

Funder types: Industry

Identifiers

NCT07020832

APL2-DGF-318

Details and patient eligibility

About

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

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

320 participants in 2 patient groups, including a placebo group

Pegceptacoplan

Active Comparator group

Description:

Administration as a 20mL IV infusion initially, then as a subcutaneous infusion

Treatment:

Drug: Pegcetacoplan

Placebo

Placebo Comparator group

Description:

Administration as a 20mL IV infusion initially, then as a subcutaneous infusion

Treatment:

Other: Placebo