Study of WAL0921 in Patients With Glomerular Kidney Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WAL0921, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, India, Malaysia, South Korea +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Overview
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
- Drug WAL0921
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions. - Drug Placebo
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Primary outcome measures
- Incidence of treatment emergent adverse events [Time frame: Baseline to Week 36]
Secondary outcome measures (4)
- Change in albuminuria [Time frame: Baseline up to Week 24]
- Change in proteinuria [Time frame: Baseline up to Week 24]
- Change in estimated glomerular filtration rate [Time frame: Baseline up to Week 24]
- Change in rate of change in eGFR [Time frame: Baseline up to Week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
India · 17 centers
- AIIMS Hospital — Raipur
- Muljibhai Patel Urological Hospital — Nadiād
- Dhiraj Hospital — Vadodara
- MS Ramaiah Medical College and Hospitals — Bangalore
- Mazumdar Shah Medical Center — Bangalore
- Manipal Hospital — Pune
- MGM Medical Care and Hospital — Sambhajinagar
- Sir Ganga Ram Hospital — New Delhi
- … and 9 more centers
United States · 9 centers
- Academic Medical Research Institute — Los Angeles
- Colorado Kidney and Vascular Care — Denver
- D & H Tamarac Research Center — Tamarac
- Fides Clinical Research — Atlanta
- Nephrology Associates of Northern Illinois and Indiana (NANI) — Hinsdale
- Dunes Clinical Research — Dakota Dunes
- Prolato Clinical Research Center — Houston
- Clinical Trial Network — Houston
- … and 1 more center
Malaysia · 6 centers
- Hospital Canselor Tuanku Muhriz UKM — Cheras
- Hospital Kuala Lumpur — Kuala Lumpur
- University Malaya Medical Centre — Kuala Lumpur
- Hospital Tengku Ampuan Afzan — Kuantan
- Hospital Sultan Idris Shah Serdang — Kajang
- Sunway Medical Centre — Petaling Jaya
South Korea · 6 centers
- Hallym University Sacred Heart Hospital — Anyang
- Pusan National University Hospital — Busan
- Seoul National University Bundang Hospital — Seongnam-si
- Severance Hospital - Yonsei Cancer Center — Seoul
- Samsung Medical Center — Soeul
- Ajou University Hospital — Suwon
Sri Lanka · 5 centers
- National Hospital of Sri Lanka — Colombo
- Jaffna Teaching Hospital — Jaffna
- Kandy National Hospital — Kandy
- Kurunegala Teaching Hospital — Kurunegala
- Kothalawala Defence University Hospital — Werahera
United Kingdom · 5 centers
- Royal Derby Hospital — Derby
- College of Life Sciences, University of Leicester — Leicester
- Barts Health NHS Trust — London
- Manchester University NHS Foundation Trust — Manchester
- Salford Royal NHS Foundation Trust — Salford
Australia · 2 centers
- Westmead Hospital — Westmead
- Western Health Sunshine Hospital — St Albans
Identifiers
NCT: NCT06466135 · WAL0921-02