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NCT06466135 · ClinicalTrials.gov registry record · Phase 2
Study of WAL0921 in Patients With Glomerular Kidney Diseases
A Phase 2 study of Diabetic Nephropathies and Primary Membranous Nephropathy, sponsored by Walden Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 9
- Study locations
NCT06466135 is a Phase 2 study of Diabetic Nephropathies and Primary Membranous Nephropathy that is actively recruiting participants, run by Walden Biosciences. The registered enrollment target is 96 participants, below the 119-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (19% lower). The trial reports 9 study locations across 5 states.
The verdict
NCT06466135, a Phase 2 study of Diabetic Nephropathies and Primary Membranous Nephropathy, is actively recruiting participants, sponsored by Walden Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG WAL0921
Study Locations (9)
Other
- Royal Derby Hospital - Derby
- College of Life Sciences, University of Leicester - Leicester
- Barts Health NHS Trust - London
- Manchester University NHS Foundation Trust - Manchester
- Salford Royal NHS Foundation Trust - Salford
Colorado
- Colorado Kidney and Vascular Care - Denver
Florida
- D & H Tamarac Research Center - Tamarac
New South Wales
- Westmead Hospital - Westmead
Victoria
- Western Health Sunshine Hospital - St Albans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06466135
The ClinicalTrials.gov registry entry for NCT06466135 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (19% lower). The listed sponsor is Walden Biosciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Diabetic Nephropathies appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06466135 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Other, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06466135 about?
NCT06466135 is a clinical study titled "Study of WAL0921 in Patients With Glomerular Kidney Diseases". 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 ...
What is the current status of trial NCT06466135?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-07-02. Estimated completion is 2026-03.
What conditions does trial NCT06466135 study?
This clinical trial studies the following conditions: Diabetic Nephropathies, Primary Membranous Nephropathy, Minimal Change Disease, Primary Focal Segmental Glomerulosclerosis, Primary Immunoglobulin A Nephropathy.
What interventions are being tested in trial NCT06466135?
The interventions under investigation include: Placebo (DRUG), WAL0921 (DRUG).
Who is sponsoring clinical trial NCT06466135?
This trial is sponsored by Walden Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06466135 being conducted?
This trial has 9 study locations across Colorado, Florida, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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