Clinical trial NCT06466135: Study of WAL0921 in Patients With Glomerular Kidney Diseases
Official title: Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Nephropathies
Primary Focal Segmental Glomerulosclerosis
Minimal Change Disease
Primary Immunoglobulin A Nephropathy
Primary Membranous Nephropathy
Keywords: DN
FSGS
TR-MCD
IgAN
PMN
Lead sponsor: Walden Biosciences
Sponsor class: INDUSTRY
First posted: 2024-06-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Change in albuminuria
timeFrame: Baseline up to Week 24
measure: Change in proteinuria
timeFrame: Baseline up to Week 24
measure: Change in estimated glomerular filtration rate
timeFrame: Baseline up to Week 24
measure: Change in rate of change in eGFR
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Kidney and Vascular Care
state: Colorado
city: Tamarac
country: United States
facility: D & H Tamarac Research Center
state: Florida
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: St Albans
country: Australia
facility: Western Health Sunshine Hospital
state: Victoria
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Leicester
country: United Kingdom
facility: College of Life Sciences, University of Leicester
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Walden Biosciences
name: Andrew Blair, MD
role: STUDY_DIRECTOR
References: