CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 114 enrolled
Drug / intervention
CSL346 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04419467
NCT04419467Phase 2Completed

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

CSL Behring·interventional·Posted Jun 5, 2020·Updated Dec 6, 2023

In Brief

A Phase 2 clinical trial evaluating CSL346 and Placebo for Diabetic Kidney Disease (DKD). Completed, enrolled 114 participants across 37 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Israel, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 5, 2020
Enrollment StartSep 14, 2020
Primary CompletionOct 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.1 years ago

Interventions

CSL346biological

VEGF-B antagonist monoclonal antibody

Placebodrug

Normal saline