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:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Unmapped
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
  • HLA-DSA (preformed and/or de novo DSA)
  • MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
  • eGFR ≥ 30 mL/min/1.73 m2
  • Must be vaccinated for S pneumoniae prior to randomization
  • Must be vaccinated for H influenzae type B (where available) prior to randomization
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 indicating nephrotic range proteinuria
  • Hemoglobin \< 8 g/dL
  • Platelets \< 100 × 109/L
  • Leucocytes \< 3 × 109/L
  • Neutrophils \< 1.5 × 109/L
  • Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization
  • Participants with history of HIV who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening
  • Evidence of hepatitis B or hepatitis C infections
  • Congenital immunodeficiency
  • History of unexplained, recurrent infection
  • Pregnant, breastfeeding, or intending to conceive within 6 months after the last dose of study intervention
  • ALT or AST \> 2.0 × ULN
  • Total bilirubin \> 2 × ULN (participants with Gilbert's syndrome can be included with total bilirubin \> 2 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)
  • Current or chronic history of liver disease that is considered clinically significant by the Investigator
  • Planned or recent treatments, \< 3 months prior to the Screening Visit, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), TCMR (including T-cell depleting therapy), excluding the SoC treatment which will be allowed and should be stable during the entire treatment
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Unmapped
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
  • HLA-DSA (preformed and/or de novo DSA)
  • MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
  • eGFR ≥ 30 mL/min/1.73 m2
  • Must be vaccinated for S pneumoniae prior to randomization
  • Must be vaccinated for H influenzae type B (where available) prior to randomization
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 indicating nephrotic range proteinuria
  • Hemoglobin \< 8 g/dL
  • Platelets \< 100 × 109/L
  • Leucocytes \< 3 × 109/L
  • Neutrophils \< 1.5 × 109/L
  • Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization
  • Participants with history of HIV who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening
  • Evidence of hepatitis B or hepatitis C infections
  • Congenital immunodeficiency
  • History of unexplained, recurrent infection
  • Pregnant, breastfeeding, or intending to conceive within 6 months after the last dose of study intervention
  • ALT or AST \> 2.0 × ULN
  • Total bilirubin \> 2 × ULN (participants with Gilbert's syndrome can be included with total bilirubin \> 2 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)
  • Current or chronic history of liver disease that is considered clinically significant by the Investigator
  • Planned or recent treatments, \< 3 months prior to the Screening Visit, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), TCMR (including T-cell depleting therapy), excluding the SoC treatment which will be allowed and should be stable during the entire treatment

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
N/A
Location
Research Site
Scottsdale, Arizona, United States, 85259
Status
N/A
Location
Research Site
Los Angeles, California, United States, 90095
Status
N/A
Location
Research Site
Orange, California, United States, 92868
Status
N/A
Location
Research Site
Tampa, Florida, United States, 33606
Status
N/A
Location
Research Site
Atlanta, Georgia, United States, 30309
Status
N/A
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