Delayed Graft FunctionPhase 3NCT07020832
Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
A Phase 3 study testing Pegcetacoplan in people with Delayed Graft Function and End Stage Renal Disease, run by Apellis Pharmaceuticals, Inc. at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, End Stage Renal Disease, Deceased Donor Kidney Transplant
- What is being tested?
- Pegcetacoplan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 18 May 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 01323-001
About this study
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
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
- Being tested
- Pegcetacoplan, Placebo
- Medical subject headings
- Delayed Graft Function, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegcetacoplanDrug
Complement (C3) Inhibitor
PlaceboOther
Sterile solution of equal volume to active arm
| Study group | Role | What they receive |
|---|---|---|
| Pegceptacoplan | Active comparator | Administration as a 20mL IV infusion initially, then as a subcutaneous infusion Receives: Drug: Pegcetacoplan |
| Placebo | Placebo comparator | Administration as a 20mL IV infusion initially, then as a subcutaneous infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of dialysis through day 90
Secondary outcomes (5)
eGFR at Week 52
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
Measured: 52 weeks following surgery
Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)
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
Measured: 7 days following surgery
eGFR at Day 90
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
Measured: 90 days following surgery
Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14
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
Measured: 14 days following surgery
Biopsy-proven rejection-free kidney allograft survival by Week 52
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
Measured: 52 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start18 May 2026
- Primary completionJun 2029 (estimated)
- Study completionJul 2030 (estimated)
Why it stopped: The study was terminated following portfolio reprioritization and reallocation of resources to other development programs. The decision was not driven by safety or efficacy concerns arising from this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020832
- Sponsor's protocol ID
- APL2-DGF-318
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07020832
- Acronym / sponsor ID
- APL2-DGF-318
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated following portfolio reprioritization and reallocation of resources to other development programs. The decision was not driven by safety or efficacy concerns arising from this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegceptacoplan | Active comparator | Drug: PegcetacoplanAdministration as a 20mL IV infusion initially, then as a subcutaneous infusion |
| Placebo | Placebo comparator | Other: PlaceboAdministration as a 20mL IV infusion initially, then as a subcutaneous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Be getting a donor kidney that meets the study's specific requirements.
Key exclusion criteria (10 listed)
- 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:
- Have had cancer in the past 5 years, unless it was:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegcetacoplanComplement (C3) Inhibitor | Drug | Pegceptacoplan |
| PlaceboSterile solution of equal volume to active arm | Other | Placebo |
Primary outcome
Time to freedom from dialysis through Day 90
Time frame: 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
5 secondary outcomes
eGFR at Week 52
Time frame: 52 weeks following surgery
Proportion of participants with DGF (defined as the need for dialysis in the 7 days posttransplant)
Time frame: 7 days following surgery
eGFR at Day 90
Time frame: 90 days following surgery
Time to achievement of ≥1200 mL of urine output in a 24-hour period through Day 14
Time frame: 14 days following surgery
Biopsy-proven rejection-free kidney allograft survival by Week 52
Time frame: 52 weeks following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegcetacoplan in people with Delayed Graft Function and End Stage Renal Disease, run by Apellis Pharmaceuticals, Inc. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to freedom from dialysis through Day 90 (time frame: Duration of dialysis through day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.