Recruiting
Phase 2

WAL0921

Sponsor:

Walden Biosciences

Code:

NCT06466135

Conditions

Diabetic Nephropathies

Primary Focal Segmental Glomerulosclerosis

Minimal Change Disease

Primary Immunoglobulin A Nephropathy

Primary Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

WAL0921

Placebo

Study Details

Brief summary:

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.

Conditions

Diabetic Nephropathies

Primary Focal Segmental Glomerulosclerosis

Minimal Change Disease

Primary Immunoglobulin A Nephropathy

Primary Membranous Nephropathy

Study ID

NCT06466135

Start date

Jul 2, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: WAL0921

Intravenous infusion of investigational drug WAL0921

placebo comparator: Placebo

Intravenous infusion of normal saline

Interventions

WAL0921

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

Placebo

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

Primary outcome measure

  • Incidence of treatment emergent adverse events [ Time Frame: Baseline to Week 36 ]

Central Contacts and Locations

Central contacts

Michelle Skupien

8573141961clinicaltrials@waldenbiosciences.com

Locations

Academic Medical Research Institute

Recruiting

Los Angeles, California, United States, 90022

Colorado Kidney and Vascular Care

Recruiting

Denver, Colorado, United States, 80012

D & H Tamarac Research Center

Recruiting

Tamarac, Florida, United States, 33321

Fides Clinical Research

Recruiting

Atlanta, Georgia, United States, 30342

Nephrology Associates of Northern Illinois and Indiana (NANI)

Recruiting

Hinsdale, Illinois, United States, 60521

Dunes Clinical Research

Recruiting

Dakota Dunes, South Dakota, United States, 57049

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

Clinical Trial Network

Recruiting

Houston, Texas, United States, 77074

Clinical Advancement Center

Recruiting

San Antonio, Texas, United States, 78212

More Information

Sponsor

Walden Biosciences

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • DN
  • FSGS
  • TR-MCD
  • IgAN
  • PMN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Walden Biosciences on 2026-08-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.