Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

• Status: Not yet recruiting
• Trial end date: 2023-03-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals

Criteria

Inclusion Criteria:

• Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, or Hypertensive Nephrosclerosis

• 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.