Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

Study Identifier:
D8560C00002
ClinicalTrials.gov Identifier:
NCT06744647
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Antibody Mediated Rejection
  • Kidney Transplantation
  • Biopsy-proven histologic scores
  • AMR
Study Drug
  • Drug: ALXN2030
  • Drug: Placebo
Date
Mar 2025 - Oct 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Kidney transplant received ≥ 6 months
  • Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
  • Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays
  • MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
  • eGFR ≥ 30 mL/min/1.73 m2
  • Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1
  • Must be vaccinated for S pneumoniae prior to randomization
  • Must be vaccinated for H influenzae type B (where available) prior to randomization
  • Body weight ≥ 50 kg at Screening
Exclusion Criteria
  • Biopsy-based diagnosis of any of the following at Screening:
  • TCMR, according to the Banff grade ≥ 1
  • Polyoma virus nephropathy
  • Severe thrombotic microangiopathy
  • Glomerulonephritis
  • ABO-incompatible transplant
  • uACR \> 2200 mg/g
  • Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
  • Planned or recent treatments, \< 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.
  • Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Antibody Mediated Rejection
  • Kidney Transplantation
  • Biopsy-proven histologic scores
  • AMR
Study Drug
  • Drug: ALXN2030
  • Drug: Placebo
Date
Mar 2025 - Oct 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Kidney transplant received ≥ 6 months
  • Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
  • Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays
  • MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
  • eGFR ≥ 30 mL/min/1.73 m2
  • Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1
  • Must be vaccinated for S pneumoniae prior to randomization
  • Must be vaccinated for H influenzae type B (where available) prior to randomization
  • Body weight ≥ 50 kg at Screening
Exclusion Criteria
  • Biopsy-based diagnosis of any of the following at Screening:
  • TCMR, according to the Banff grade ≥ 1
  • Polyoma virus nephropathy
  • Severe thrombotic microangiopathy
  • Glomerulonephritis
  • ABO-incompatible transplant
  • uACR \> 2200 mg/g
  • Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
  • Planned or recent treatments, \< 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.
  • Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes

Protocol Summary

The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.

Trial Locations

Location
Status
Location
Research Site
Birmingham, Alabama, United States, 35249
Status
Recruiting
Location
Research Site
Scottsdale, Arizona, United States, 85259
Status
Not yet recruiting
Location
Research Site
Los Angeles, California, United States, 90095
Status
Recruiting
Location
Research Site
Orange, California, United States, 92868
Status
Recruiting
Location
Research Site
Tampa, Florida, United States, 33606
Status
Recruiting
Location
Research Site
Atlanta, Georgia, United States, 30309
Status
Recruiting
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