Study of WAL0921 in Patients With Glomerular Kidney Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WAL0921

Intravenous infusion of investigational drug WAL0921

Group Type EXPERIMENTAL

WAL0921

Intervention Type DRUG

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

Placebo

Intravenous infusion of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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WAL0921

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Blair, MD

Role: STUDY_DIRECTOR

Walden Biosciences

Locations

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Colorado Kidney and Vascular Care

Denver, Colorado, United States

Site Status RECRUITING

D & H Tamarac Research Center

Tamarac, Florida, United States

Site Status RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status ACTIVE_NOT_RECRUITING

Western Health Sunshine Hospital

St Albans, Victoria, Australia

Site Status ACTIVE_NOT_RECRUITING