Study of WAL0921 in Patients With Glomerular Kidney Diseases
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy, Primary Membranous Nephropathy
In brief
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.
Key facts
- Study ID
- NCT06466135
- Run by
- Walden Biosciences
- People needed
- 96
- Starts
- 2024-07-02
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Dunes Clinical Research — Dakota Dunes, South Dakota, United States (enrolling)
- Prolato Clinical Research Center — Houston, Texas, United States (enrolling)
- Clinical Trial Network — Houston, Texas, United States (enrolling)
- Hospital Canselor Tuanku Muhriz UKM — Cheras, Kuala Lumpur, Malaysia (enrolling)
- Hospital Kuala Lumpur — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
- University Malaya Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia (enrolling)
- Hospital Tengku Ampuan Afzan — Kuantan, Pahang, Malaysia (enrolling)
- Hospital Sultan Idris Shah Serdang — Kajang, Selangor, Malaysia (enrolling)
- Sunway Medical Centre — Petaling Jaya, Selangor, Malaysia (enrolling)
- Hallym University Sacred Heart Hospital — Anyang, South Korea (enrolling)
- Pusan National University Hospital — Busan, South Korea (enrolling)
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (enrolling)
- Severance Hospital - Yonsei Cancer Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Soeul, South Korea (enrolling)
- Ajou University Hospital — Suwon, South Korea (enrolling)
- Clinical Advancement Center — San Antonio, Texas, United States (enrolling)
- Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
- Western Health Sunshine Hospital — St Albans, Victoria, Australia (enrolling)
- Colorado Kidney and Vascular Care — Denver, Colorado, United States (enrolling)
- D & H Tamarac Research Center — Tamarac, Florida, United States (enrolling)
- Royal Derby Hospital — Derby, United Kingdom (enrolling)
- College of Life Sciences, University of Leicester — Leicester, United Kingdom (enrolling)
- Fides Clinical Research — Atlanta, Georgia, United States (enrolling)
- Nephrology Associates of Northern Illinois and Indiana (NANI) — Hinsdale, Illinois, United States (enrolling)
- Academic Medical Research Institute — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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