A Phase 2 interventional study of WAL0921 and Placebo in Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis and Minimal Change Disease, sponsored by Walden Biosciences. Recruiting at 50 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Walden Biosciences · Phase 2, Interventional, and Treatment
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.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's planned enrollment of 96 is above the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Walden Biosciences is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous infusion of investigational drug WAL0921
Drug: WAL0921
Intravenous infusion of normal saline
Drug: Placebo
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Incidence of treatment emergent adverse events
Time frame: Baseline to Week 36
Change in albuminuria
Percent change in urine albumin-creatinine ratio (UACR)
Time frame: Baseline up to Week 24
Change in proteinuria
Percent change in urine protein-creatinine ratio (UPCR)
Time frame: Baseline up to Week 24
Change in estimated glomerular filtration rate
Percent change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline up to Week 24
Change in rate of change in eGFR
Slope of eGFR
Time frame: Baseline up to Week 24
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