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NCT Number: NCT06466135

Study of WAL0921 in Patients With Glomerular Kidney Diseases

This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis [FSGS], treatment-resistant minimal change disease [TR MCD], primary immunoglobulin A nephropathy [IgAN], and primary membranous nephropathy [PMN]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.

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Key information

Conditions

Diabetic Nephropathies Autoimmune Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Minimal Change Disease Nephritis Nephrosis Nephrosis, Lipoid Primary Focal Segmental Glomerulosclerosis Primary Immunoglobulin A Nephropathy Primary Membranous Nephropathy Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults, age 18-75 years
  • Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy
  • eGFR greater than or equal to 30 mL/min/1.73 m2

Exclusion criteria

  • Currently pregnant or planning to become pregnant
  • History of organ transplantation
  • History of alcohol or substance use disorder
  • Acute dialysis or acute kidney injury within 6 months of Screening
  • Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements

Treatment and study plan

WAL0921

Drug

Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.

Placebo

Drug

Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: Baseline to Week 36

Secondary outcomes

  1. Change in albuminuria

    Time frame: Baseline up to Week 24

    Percent change in urine albumin-creatinine ratio (UACR)

  2. Change in proteinuria

    Time frame: Baseline up to Week 24

    Percent change in urine protein-creatinine ratio (UPCR)

  3. Change in estimated glomerular filtration rate

    Time frame: Baseline up to Week 24

    Percent change in estimated glomerular filtration rate (eGFR)

  4. Change in rate of change in eGFR

    Time frame: Baseline up to Week 24

    Slope of eGFR

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Skupien

CONTACT

[email protected]

8573141961

Sponsors and collaborators

Lead sponsor

Walden Biosciences

Industry

Registry information

Official study title

Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2024
Registry last updated
Apr 2, 2026

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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