Study of WAL0921 in Patients With Glomerular Kidney Diseases

Phase 2RecruitingNCT06466135

Walden Biosciences96 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

WAL0921DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (50)

Academic Medical Research Institute

Los Angeles, California, United States

RECRUITING

Colorado Kidney and Vascular Care

Denver, Colorado, United States

RECRUITING

D & H Tamarac Research Center

Tamarac, Florida, United States

RECRUITING

Fides Clinical Research

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events

Time frame: Baseline to Week 36

Secondary Outcomes

Change in albuminuria

Percent change in urine albumin-creatinine ratio (UACR)

Time frame: Baseline up to Week 24

Change in proteinuria

Percent change in urine protein-creatinine ratio (UPCR)

Time frame: Baseline up to Week 24

Change in estimated glomerular filtration rate

Percent change in estimated glomerular filtration rate (eGFR)

Time frame: Baseline up to Week 24

Change in rate of change in eGFR

Slope of eGFR

Time frame: Baseline up to Week 24

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Overview

Conditions

Interventions

Eligibility

Locations (50)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts