A Phase 3 interventional study of Pegcetacoplan and Placebo in Delayed Graft Function, End Stage Renal Disease and Deceased Donor Kidney Transplant, sponsored by Apellis Pharmaceuticals, Inc.. Withdrawn at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Apellis Pharmaceuticals, Inc. (part of Biogen) · Phase 3, Interventional, and Treatment
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
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
Browse Delayed Graft Function studies →Apellis Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
First submitted before Apellis Pharmaceuticals, Inc. became part of Biogen.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:
Be at low to medium risk of transplant rejection, and be scheduled to receive:
Have received certain vaccines before starting the study treatment, specifically:
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.
Exclusion Criteria:
Have or had recently had any of the following infections:
Have had cancer in the past 5 years, unless it was:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration as a 20mL IV infusion initially, then as a subcutaneous infusion
Drug: Pegcetacoplan
Administration as a 20mL IV infusion initially, then as a subcutaneous infusion
Other: Placebo
Complement (C3) Inhibitor
Sterile solution of equal volume to active arm
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
Time frame: Duration of dialysis through day 90
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 weeks following surgery
Started May 2026 (actual). Primary completion is estimated for Jun 2029, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegcetacoplan
Apellis Pharmaceuticals, Inc. →