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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06466135
Other study ID # WAL0921-02
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 17, 2024
Est. completion date March 2026

Study information

Verified date June 2024
Source Walden Biosciences
Contact Michelle Skupien
Phone 8573141961
Email clinicaltrials@waldenbiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date March 2026
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion 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 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


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Walden Biosciences

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment emergent adverse events Baseline to Week 36
Secondary Change in albuminuria Percent change in urine albumin-creatinine ratio (UACR) Baseline up to Week 24
Secondary Change in proteinuria Percent change in urine protein-creatinine ratio (UPCR) Baseline up to Week 24
Secondary Change in estimated glomerular filtration rate Percent change in estimated glomerular filtration rate (eGFR) Baseline up to Week 24
Secondary Change in rate of change in eGFR Slope of eGFR Baseline up to Week 24
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