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

NCT07020832 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: APL2-DGF-318
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to freedom from 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

  Duration of dialysis through day 90

Secondary Outcomes (5)

• eGFR at Week 52

  52 weeks following surgery

• Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)

  7 days following surgery

• eGFR at Day 90

  90 days following surgery

• Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14

  14 days following surgery

• Biopsy-proven rejection-free kidney allograft survival by Week 52

  52 weeks following surgery

Study Arms (2)

Pegceptacoplan

ACTIVE COMPARATOR

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

Drug: Pegcetacoplan

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Pegcetacoplan DRUG

Complement (C3) Inhibitor

Pegceptacoplan

Placebo OTHER

Sterile solution of equal volume to active arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years
• Have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor.
• 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.
• Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:
• It cannot be due to a serious infection or a serious blood clot in your previous transplant.
• Your calculated Panel Reactive Antibody (CPRA) level must be below 50%.
• Be getting a donor kidney that meets the study's specific requirements.
• Be at low to medium risk of transplant rejection, and be scheduled to receive:
• A medication called ATG as part of your transplant procedure.
• Steroids (corticosteroids) as part of your treatment at the time of screening.
• A medication called tacrolimus (or a similar drug) after your transplant, according to usual medical practice.
• Have received certain vaccines before starting the study treatment, specifically:
• Pneumococcal (S. pneumoniae)
• Meningococcal (N. meningitidis types A, C, W, Y, and B)
• Haemophilus influenzae type B

You may not qualify if:

• 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).
• Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs.
• Weigh less than 20kg or more than 120kg at screening.
• Have or had recently had any of the following infections:
• Hepatitis B or Hepatitis C (unless treated and no longer active).
• HIV (human immunodeficiency virus) at any time.
• Have had cancer in the past 5 years, unless it was:
• A small, treated skin cancer (like basal or squamous cell), or
• A very small kidney cancer that was found early and treated.
• Have received any other organ transplant (except for one previous kidney transplant), or are scheduled for a transplant involving more than one organ.

Sponsors & Collaborators

• Apellis Pharmaceuticals, Inc.: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 01323-001, Brazil

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function; Kidney Failure, Chronic

Interventions

pegcetacoplan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Apellis Clinical Trial Information Line

CONTACT

617-977-5700; clinicaltrials@apellis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2025-06

Locations

BR (1)