Deceased Donor Kidney Transplant, Delayed Graft Function, End Stage Renal Disease
Conditions
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
Interventions
DRUGPegcetacoplan
Complement (C3) Inhibitor
OTHERPlacebo
Sterile solution of equal volume to active arm
Sponsors
Apellis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 equivalent to ≤1 cup). 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 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed