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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Colorado Kidney and Vascular Care
RECRUITING
Denver
Florida
D & H Tamarac Research Center
RECRUITING
Tamarac
Other Locations
Australia
Western Health Sunshine Hospital
ACTIVE_NOT_RECRUITING
St Albans
Westmead Hospital
ACTIVE_NOT_RECRUITING
Westmead
United Kingdom
Royal Derby Hospital
NOT_YET_RECRUITING
Derby
College of Life Sciences, University of Leicester
NOT_YET_RECRUITING
Leicester
Barts Health NHS Trust
NOT_YET_RECRUITING
London
Manchester University NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Salford Royal NHS Foundation Trust
NOT_YET_RECRUITING
Salford
Contact Information
Primary
Michelle Skupien
clinicaltrials@waldenbiosciences.com
8573141961
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2026-03
Participants
Target number of participants: 96
Treatments
Experimental: WAL0921
Intravenous infusion of investigational drug WAL0921
Placebo_comparator: Placebo
Intravenous infusion of normal saline
Sponsors
Leads: Walden Biosciences

This content was sourced from clinicaltrials.gov