Phase 2
N=114
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
Bottom Line
View on ClinicalTrials.gov: NCT04419467 ↗Enrolled (actual)
114
Serious AEs
12.5%
Results posted
Dec 2023
Primary outcome: Primary: Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR) — 3.2; 17.7; 5.4 Geometric Mean of Percent Change — p=0.485
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CSL346 (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR) |
3.2; 17.7; 5.4 | 0.485 |
| SECONDARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) |
22; 23; 32 | — |
| SECONDARY Percentage of Subjects With TEAEs |
75.9; 79.3; 59.3 | — |
| SECONDARY Number of Subjects With Adverse Events of Special Interest (AESIs) |
10; 6; 13 | — |
| SECONDARY Percentage of Subjects With AESIs |
34.5; 20.7; 24.1 | — |
| SECONDARY Observed Value and Mean Change From Baseline in Serum Creatinine |
1.273; 1.321; 1.207; 1.306; 0.032; 1.269 | — |
| SECONDARY Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) |
65.38; 64.94; 71.95; 63.62; -1.77; 66.31 | — |
| SECONDARY Observed Value and Mean Change From Baseline in Systolic Blood Pressure |
133.4; 131.4; 133.9; 135.1; 1.7; 133.9 | — |
| SECONDARY Observed Value and Mean Change From Baseline in Diastolic Blood Pressure |
75.5; 73.4; 75.5; 76.1; 0.6; 75.4 | — |
| SECONDARY Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples |
234.26; 182.32 | — |
| SECONDARY Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples |
0.52; 0.55 | — |
| SECONDARY Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples |
34.70; 67.88 | — |
| SECONDARY Tmax After First SC Dose of CSL346 in Serum Samples |
168.05; 167.58 | — |
| SECONDARY Area Under the Concentration-time Curve in First Dosing Interval |
19374.474; 37225.571 | — |
| SECONDARY Trough Concentration After Each Dose |
15.306; 28.215; 16.686; 31.541; 15.959; 31.522 | — |
| SECONDARY Number of Subjects Positive for Anti-drug Antibodies |
4; 0; 4; 0; 5; 0 | — |
| SECONDARY Percentage of Subjects Positive for Anti-drug Antibodies |
13.8; 0; 14.3; 0; 17.9; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes mellitus (T2DM)
- Urinary ACR ≥ 150 mg/g
- eGFR > 20 mL/min/1.73m2
- Glycosylated HbA1c the upper reference limit
- b-type natriuretic peptide > 200 pg/mL
- ALT > 2x the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT04419467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.