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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
320
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 52 weeks following surgery