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Diabetic Kidney Disease (DKD)Phase 2NCT04419467

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

A Phase 2 study testing CSL346 in people with Diabetic Kidney Disease (DKD), run by CSL Behring at 37 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Diabetic Kidney Disease (DKD)
What is being tested?
CSL346
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
37 sitesin 6 countries
Study dates
14 Sep 2020to 24 Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

37 sites in 6 countries.

37 sites in 6 countries

United States22 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • California Kidney Specialists (CKS) - Citrus Office

    Covina, California, 91702

  • Valley Research - Fresno

    Fresno, California, 93720

  • Physicians East, P.A. - Endocrinology

    Greenville, North Carolina, 27834

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Juno Research, L.L.C.

    Houston, Texas, 77040

  • The Endocrine Center

    Houston, Texas, 77079

  • Palm Medical Group, LLC - Las Vegas

    Las Vegas, Nevada, 89148

  • Torrance Clinical Research (TCR) - Lomita

    Lomita, California, 90717

  • Renal Medical Associate/NARI

    Lynwood, California, 90260

  • Omega Clinical Research

    Metairie, Louisiana, 70006

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232

  • Amicis Research Center

    Northridge, California, 91324

  • California Medical Research Associates, Inc

    Northridge, California, 91324

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Riverside Nephrology Group

    Riverside, California, 92503

  • Renal Associates, P.A. - San Antonio

    San Antonio, Texas, 78215

  • Primary Care Providers of Texas

    San Antonio, Texas, 78224

  • Diabetes and Metabolism Specialists (DMS) - San Antonio

    San Antonio, Texas, 78231

  • Renal and Transplant Associates

    Springfield, Massachusetts, 01107

  • Center for Thyroid & Parathyroid Disorders

    Staten Island, New York, 10301

Other trials in United States

Australia6 sites

  • Lyell McEwin Hospital

    Elizabeth Vale, 5112

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • The Austin Hospital

    Heidelberg, Victoria, 3084

  • Hunter Diabetes Centre - The AIM Centre

    Merewether, New South Wales, 2291

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3052

  • Sunshine Hospital

    St Albans, Victoria, 3021

Other trials in Australia

New Zealand4 sites

  • Middlemore Hospital

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8011

  • Lipid and Diabetes Research Group

    Christchurch, 8011

  • Endocrine Associates - Wellington

    Wellington, 6140

Other trials in New Zealand

Israel2 sites

  • 3760045 - Kaplan Medical Center

    Rehovot, 76100

  • 3760044 - Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Puerto Rico2 sites

  • Fundación de Investigación

    San Juan, 00927

  • University of Puerto Rico - Puerto Rico Clinical and TRC

    San Juan, 00935

Other trials in Puerto Rico

Canada1 site

  • 1240130 - University Health Network

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official 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

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.

Being tested
CSL346, Placebo
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSL346Biological

    VEGF-B antagonist monoclonal antibody

  • PlaceboDrug

    Normal saline

Study groups in NCT04419467
Study groupRoleWhat they receive
CSL346 (low dose)ExperimentalAdministered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Receives: Biological: CSL346
CSL346 (high dose)ExperimentalAdministered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Receives: Biological: CSL346
PlaceboPlacebo comparatorAdministered as a single IV loading dose followed by SC infusions
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline up to Week 16

Secondary outcomes (16)

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

    Measured: Up to 24 weeks

  2. Percentage of Subjects With TEAEs

    Measured: Up to 24 weeks

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

    Data are presented for treatment-emergent AESIs.

    Measured: Up to 24 weeks

  4. Percentage of Subjects With AESIs

    Data are presented for treatment-emergent AESIs.

    Measured: Up to 24 weeks

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

    Measured: Baseline up to 24 weeks

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

    Measured: Baseline up to 24 weeks

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

    Measured: Baseline up to 24 weeks

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

    Measured: Baseline up to 24 weeks

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

    Measured: 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

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

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

    Measured: From Day 1 to Day 29

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

    Measured: From Day 1 to Day 29

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

    Measured: From Day 1 to Day 29

  14. Trough Concentration After Each Dose

    Measured: 29 days after each dose

  15. Number of Subjects Positive for Anti-drug Antibodies

    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.

    Measured: Weeks 4, 8, and 16

  16. Percentage of Subjects Positive for Anti-drug Antibodies

    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.

    Measured: Weeks 4, 8, and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start14 Sep 2020
  3. Primary completion24 Oct 2022
  4. Study completion24 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419467
Sponsor's protocol ID
CSL346_2001
Status last verified
Dec 2023
First submitted
3 Jun 2020
Last updated
6 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

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.

    PubMed 39150859

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CSL346 in people with Diabetic Kidney Disease (DKD), run by CSL Behring at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Australia, New Zealand, Israel, Puerto Rico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR) (time frame: Baseline up to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04419467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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