Study of WAL0921 in Patients With Glomerular Kidney Diseases

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466135
• Other study ID #: WAL0921-02
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Glomerulonephritis, IGA
• Glomerulonephritis, Membranous
• Glomerulosclerosis, Focal Segmental
• Kidney Diseases
• Minimal Change Disease
• Nephrosis, Lipoid
• Primary Focal Segmental Glomerulosclerosis
• Primary Membranous Nephropathy

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