WAL0921 in Patients with Glomerular Kidney Diseases and Proteinuria

• Research type

  Research Study

• Full title

  Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients with Glomerular Kidney Diseases and Proteinuria

• IRAS ID

  1010994

• Contact name

  Blaine McKee

• Contact email

  blaine.mckee@waldenbiosciences.com

• Sponsor organisation

  Walden Biosciences, Inc.

• Eudract number

  2024-515088-78

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT06466135

• Research 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.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  25/SC/0237

• Date of REC Opinion

  29 Sep 2025

• REC opinion

  Further Information Favourable Opinion