Study of WAL0921 in Patients With Glomerular Kidney Diseases

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWalden Biosciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • WAL0921
  • Placebo

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators