Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Alexion Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Proteinuria

Treatments

Drug: ALXN1720

Study type

Interventional

Funder types

Industry

Identifiers

NCT05314231

ALXN1720-NEPH-102

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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.