Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

NCT05314231 | Completed Phase 1

• 1 other identifier: ALXN1720-NEPH-102
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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

Keywords

Proteinuria; Glomerular Disease; Chronic Kidney Disease; Lupus Nephritis; Immunoglobulin A Nephropathy; Primary Membranous Nephropathy; Focal Segmental Glomerulosclerosis; Diabetic Nephropathy; Hypertensive Nephrosclerosis; Minimal Change Disease; Thin Basement Membrane Nephropathy; Membranoproliferative Glomerulonephritis (all forms)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events

  Day 1 (Predose) through Follow-up (Day 92)

• 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

• Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720

  Day 1 (predose) through Day 57

Study Arms (1)

ALXN1720

EXPERIMENTAL

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

Drug: ALXN1720

Interventions

ALXN1720 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).

ALXN1720

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (2)

Clinical Trial Site 2

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Clinical Trial Site 1

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Proteinuria; Renal Insufficiency, Chronic; Lupus Nephritis; Glomerulonephritis, IGA; Glomerulosclerosis, Focal Segmental; Diabetic Nephropathies; Nephrosis, Lipoid; Hematuria, Benign Familial; Glomerulonephritis, Membranoproliferative

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Glomerulonephritis; Nephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Nephrosis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: June 29, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)