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Completed

NCT Number: NCT05314231

Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

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.

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Key information

Conditions

Proteinuria Autoimmune Diseases Chronic Disease Connective Tissue Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Glomerulonephritis, Membranoproliferative Glomerulosclerosis, Focal Segmental Hematuria, Benign Familial Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Nephritis Nephrosis Nephrosis, Lipoid Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Skin and Connective Tissue Diseases Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site 2, Anyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Serum Concentration of ALXN1720

    Time frame: Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: Day 1 (Predose) through Follow-up (Day 92)

  2. Serum Concentration of Free and Total Complement Component 5 (C5)

    Time frame: Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57

  3. Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720

    Time frame: Day 1 (predose) through Day 57

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2022
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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