Diabetic Nephropathies, Minimal Change Disease, Primary Focal Segmental Glomerulosclerosis, Primary Immunoglobulin A Nephropathy, Primary Membranous Nephropathy
Conditions
Keywords
DN, FSGS, TR-MCD, IgAN, PMN
Brief 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.
Interventions
DRUGWAL0921
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
DRUGPlacebo
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Sponsors
Walden Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events | Baseline to Week 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in albuminuria | Baseline up to Week 24 | Percent change in urine albumin-creatinine ratio (UACR) |
| Change in proteinuria | Baseline up to Week 24 | Percent change in urine protein-creatinine ratio (UPCR) |
| Change in estimated glomerular filtration rate | Baseline up to Week 24 | Percent change in estimated glomerular filtration rate (eGFR) |
| Change in rate of change in eGFR | Baseline up to Week 24 | Slope of eGFR |
Countries
Australia, India, Malaysia, South Korea, Sri Lanka, United Kingdom, United States
Contacts
CONTACTMichelle Skupien
STUDY_DIRECTORRekha Abichandani, MD
Walden Biosciences
Outcome results
None listed