Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease

NCT04419467 ↗

Phase 2 Completed 114 enrolled CSL Behring

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2020-09-14
Primary completion: 2022-10-24
Completion: 2022-10-24

Outcome

Missed primary endpoint

paper CSL346 did not significantly reduce UACR compared with placebo at week 16 PMID 39150859 ↗

registry analysis (superiority test); CSL346 (Low Dose) vs Placebo; p = 0.485 NCT04419467 ↗

registry analysis (superiority test); CSL346 (High Dose) vs Placebo; p = 0.750 NCT04419467 ↗

Publications

Cooper M, Cherney DZI, Greene TH, Heerspink HJL, Jardine M, Lewis JB, Wong MG, Baquero E, Heise M, Jochems J, Lanchoney D, Liss C, Reiser D, Scotney P, Velkoska E, Dwyer JP. Vascular Endothelial Growth Factor-B Blockade with CSL346 in Diabetic Kidney Disease: A Phase 2A Randomized Controlled Trial. J Am Soc Nephrol. 2024 Nov 1;35(11):1546-1557. doi: 10.1681/ASN.0000000000000438. Epub 2024 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	REFLOCIBART	Monoclonal antibody	8 mg/kg	Intravenous
Subject	REFLOCIBART	Monoclonal antibody	16 mg/kg	Intravenous