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RecruitingPhase 2

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Walden Biosciences · NCT06466135

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
96
US sites recruiting
9
Study start
July 2, 2024
Record last updated
August 3, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: WAL0921; Placebo

Conditions: Diabetic Nephropathies; Primary Focal Segmental Glomerulosclerosis; Minimal Change Disease; Primary Immunoglobulin A Nephropathy; Primary Membranous Nephropathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Michelle Skupien · 8573141961 · clinicaltrials@waldenbiosciences.com
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Study of WAL0921 in Patients With Glomerular Kidney Diseases (NCT06466135) | Bored Studies