Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Study Identifier:
ALXN1720-NEPH-102
ClinicalTrials.gov Identifier:
NCT05314231
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1720
Date
Jun 2022 - May 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 19 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
  • Proteinuria \>=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
  • Body weight ≥ 40 kg at Screening
Exclusion Criteria
  • Kidney transplant
  • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 during Screening
  • Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
  • Treatment with complement inhibitors at any time.
  • Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.
  • Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Sex
Female & Male
Age
19 - 65 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1720
Date
Jun 2022 - May 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 19 - 65 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
  • Proteinuria \>=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
  • Body weight ≥ 40 kg at Screening
Exclusion Criteria
  • Kidney transplant
  • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 during Screening
  • Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
  • Treatment with complement inhibitors at any time.
  • Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.
  • Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Protocol Summary

The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.

Trial Locations

Location
Status
Location
Clinical Trial Site 2
Anyang-si, Gyeonggi-do, Republic of Korea, 14068
Status
N/A
Location
Clinical Trial Site 1
Seoul, Republic of Korea, 03080
Status
N/A