Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

NCT ID: NCT05314231

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2023-05-31

Brief 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.

Conditions

Proteinuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALXN1720

Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.

Group Type: EXPERIMENTAL

ALXN1720

Intervention Type: DRUG

All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).

Interventions

ALXN1720

All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site 2

Anyang-si, Gyeonggi-do, South Korea

Clinical Trial Site 1

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ALXN1720-NEPH-102

Identifier Type: -

Identifier Source: org_study_id