Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Proteinuria Clinical Trial

Official title:

A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314231
• Other study ID #: ALXN1720-NEPH-102
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Proteinuria

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Site 2	Anyang-Si	Gyeonggi-do
Korea, Republic of	Clinical Trial Site 1	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Alexion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Concentration of ALXN1720		Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
Secondary	Number of Participants With Treatment-Emergent Adverse Events		Day 1 (Predose) through Follow-up (Day 92)
Secondary	Serum Concentration of Free and Total Complement Component 5 (C5)		Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
Secondary	Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720		Day 1 (predose) through Day 57