Study of WAL0921 in Patients With Glomerular Kidney Diseases

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Condition
Diabetic Nephropathies
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Kidney and Vascular Care, Denver, Colorado, United States, 80012

Tamarac

D & H Tamarac Research Center, Tamarac, Florida, United States, 33321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults, age 18-65 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Walden Biosciences,

Andrew Blair, MD, STUDY_DIRECTOR, Walden Biosciences

Study Record Dates

2026-03