Study of WAL0921 in Patients With Glomerular Kidney Diseases

Part of paid clinical trials in Los Angeles, California.

Sponsor
Walden Biosciences
Study ID
NCT06466135
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diabetic Nephropathies
  • Minimal Change Disease
  • Primary Focal Segmental Glomerulosclerosis
  • Primary Immunoglobulin A Nephropathy
  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 2, 2024
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WAL0921
    Intravenous infusion of investigational drug WAL0921
  • Placebo Comparator: Placebo
    Intravenous infusion of normal saline

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Academic Medical Research InstituteLos AngelesCalifornia90022-
Colorado Kidney and Vascular CareDenverColorado80012-
D & H Tamarac Research CenterTamaracFlorida33321-
Fides Clinical ResearchAtlantaGeorgia30342-
Nephrology Associates of Northern Illinois and Indiana (NANI)HinsdaleIllinois60521-
Dunes Clinical ResearchDakota DunesSouth Dakota57049-
Clinical Trial NetworkHoustonTexas77074-
Prolato Clinical Research CenterHoustonTexas77054-
Clinical Advancement CenterSan AntonioTexas78212-

Find similar trials in Los Angeles, CA

By research site
Academic Medical Research Institute· Los Angeles, CAColorado Kidney and Vascular Care· Denver, COD & H Tamarac Research Center· Tamarac, FLFides Clinical Research· Atlanta, GANephrology Associates of Northern Illinois and Indiana (NANI)· Hinsdale, ILDunes Clinical Research· Dakota Dunes, SD

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