Trials / Completed
CompletedNCT04419467
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL346 | VEGF-B antagonist monoclonal antibody |
| DRUG | Placebo | Normal saline |
Timeline
- Start date
- 2020-09-14
- Primary completion
- 2022-10-24
- Completion
- 2022-10-24
- First posted
- 2020-06-05
- Last updated
- 2023-12-06
- Results posted
- 2023-12-06
Locations
37 sites across 6 countries: United States, Australia, Canada, Israel, New Zealand, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04419467. Inclusion in this directory is not an endorsement.