Study of WAL0921 in Patients With Glomerular Kidney Diseases
Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
1 other identifier
interventional
96
7 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedStudy Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 2, 2026
March 1, 2026
2.7 years
June 12, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment emergent adverse events
Baseline to Week 36
Secondary Outcomes (4)
Change in albuminuria
Baseline up to Week 24
Change in proteinuria
Baseline up to Week 24
Change in estimated glomerular filtration rate
Baseline up to Week 24
Change in rate of change in eGFR
Baseline up to Week 24
Study Arms (2)
WAL0921
EXPERIMENTALIntravenous infusion of investigational drug WAL0921
Placebo
PLACEBO COMPARATORIntravenous infusion of normal saline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Colorado Kidney and Vascular Care
Denver, Colorado, 80012, United States
D & H Tamarac Research Center
Tamarac, Florida, 33321, United States
Fides Clinical Research
Atlanta, Georgia, 30342, United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Hinsdale, Illinois, 60521, United States
Dunes Clinical Research
Dakota Dunes, South Dakota, 57049, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Clinical Advancement Center
San Antonio, Texas, 78212, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Western Health Sunshine Hospital
St Albans, Victoria, 3021, Australia
AIIMS Hospital
Raipur, Chhattisgarh, 492099, India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, 387003, India
Dhiraj Hospital
Vadodara, Gujarat, 391760, India
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054, India
Mazumdar Shah Medical Center
Bangalore, Karnataka, 560099, India
Manipal Hospital
Pune, Maharashtra, 411045, India
MGM Medical Care and Hospital
Sambhajinagar, Maharashtra, 431003, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Max Super Speciality Hospital
Patparganj, National Capital Territory of Delhi, 110092, India
SUM Hospital
Bhubaneswar, Odisha, 751029, India
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, 500082, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014, India
Nutema Hospital
Meerut, Uttar Pradesh, 250002, India
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun, Uttarakhand, 248001, India
NRS Medical College and Hospital Kolkata
Kolkata, West Bengal, 700014, India
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, 43000, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, 47500, Malaysia
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, 03722, South Korea
Samsung Medical Center
Soeul, 06351, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
National Hospital of Sri Lanka
Colombo, 00700, Sri Lanka
Jaffna Teaching Hospital
Jaffna, 40000, Sri Lanka
Kandy National Hospital
Kandy, 20000, Sri Lanka
Kurunegala Teaching Hospital
Kurunegala, 60000, Sri Lanka
Kothalawala Defence University Hospital
Werahera, 10290, Sri Lanka
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
College of Life Sciences, University of Leicester
Leicester, LE1 7RH, United Kingdom
Barts Health NHS Trust
London, E1 2ES, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrew Blair, MD
Walden Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 20, 2024
Study Start
July 2, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03