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Completed

NCT Number: NCT04419467

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

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.

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Key information

Conditions

Diabetic Kidney Disease (DKD) Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunter Diabetes Centre - The AIM Centre, Merewether, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 12%

Exclusion criteria

  • Current diagnosis of type 1 diabetes mellitus
  • History of acute kidney injury or chronic dialysis/renal transplant
  • Uncontrolled hypertension or class III / IV heart failure
  • Left ventricular ejection fraction < 50% by echocardiogram
  • Troponin-I > the upper reference limit
  • b-type natriuretic peptide > 200 pg/mL
  • ALT > 2x the upper limit of normal

Treatment and study plan

CSL346

Biological

VEGF-B antagonist monoclonal antibody

Placebo

Drug

Normal saline

Primary outcomes

  1. Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)

    Time frame: Baseline up to Week 16

    Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.

Secondary outcomes

  1. Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 24 weeks

  2. Percentage of Subjects With TEAEs

    Time frame: Up to 24 weeks

  3. Number of Subjects With Adverse Events of Special Interest (AESIs)

    Time frame: Up to 24 weeks

    Data are presented for treatment-emergent AESIs.

  4. Percentage of Subjects With AESIs

    Time frame: Up to 24 weeks

    Data are presented for treatment-emergent AESIs.

  5. Observed Value and Mean Change From Baseline in Serum Creatinine

    Time frame: Baseline up to 24 weeks

  6. Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline up to 24 weeks

  7. Observed Value and Mean Change From Baseline in Systolic Blood Pressure

    Time frame: Baseline up to 24 weeks

  8. Observed Value and Mean Change From Baseline in Diastolic Blood Pressure

    Time frame: Baseline up to 24 weeks

  9. Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples

    Time frame: Up to 120 minutes after the IV loading dose for CSL346

  10. Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples

    Time frame: Up to 120 minutes after the IV loading dose for CSL346

  11. Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples

    Time frame: From Day 1 to Day 29

  12. Tmax After First SC Dose of CSL346 in Serum Samples

    Time frame: From Day 1 to Day 29

  13. Area Under the Concentration-time Curve in First Dosing Interval

    Time frame: From Day 1 to Day 29

  14. Trough Concentration After Each Dose

    Time frame: 29 days after each dose

  15. Number of Subjects Positive for Anti-drug Antibodies

    Time frame: Weeks 4, 8, and 16

    Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.

  16. Percentage of Subjects Positive for Anti-drug Antibodies

    Time frame: Weeks 4, 8, and 16

    Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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