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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06466135




Registration number
NCT06466135
Ethics application status
Date submitted
12/06/2024
Date registered
20/06/2024
Date last updated
27/01/2025

Titles & IDs
Public title
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Scientific title
Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Secondary ID [1] 0 0
WAL0921-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathies 0 0
Primary Focal Segmental Glomerulosclerosis 0 0
Minimal Change Disease 0 0
Primary Immunoglobulin A Nephropathy 0 0
Primary Membranous Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - WAL0921
Treatment: Drugs - Placebo

Experimental: WAL0921 - Intravenous infusion of investigational drug WAL0921

Placebo comparator: Placebo - Intravenous infusion of normal saline


Treatment: Drugs: WAL0921
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.

Treatment: Drugs: Placebo
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events
Timepoint [1] 0 0
Baseline to Week 36
Secondary outcome [1] 0 0
Change in albuminuria
Timepoint [1] 0 0
Baseline up to Week 24
Secondary outcome [2] 0 0
Change in proteinuria
Timepoint [2] 0 0
Baseline up to Week 24
Secondary outcome [3] 0 0
Change in estimated glomerular filtration rate
Timepoint [3] 0 0
Baseline up to Week 24
Secondary outcome [4] 0 0
Change in rate of change in eGFR
Timepoint [4] 0 0
Baseline up to Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Walden Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Blair, MD
Address 0 0
Walden Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Skupien
Address 0 0
Country 0 0
Phone 0 0
8573141961
Fax 0 0
Email 0 0
clinicaltrials@waldenbiosciences.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06466135