Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466135
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-12
Brief Title:
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Sponsor:
Walden Biosciences
Organization:
Walden Biosciences
Study Overview
Official Title:
Safety Efficacy Pharmacokinetics and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None