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Diabetic Kidney DiseasePhase 2NCT03449199

Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

A Phase 2 study testing TMX-049 in people with Diabetic Kidney Disease, run by Teijin America, Inc. at 55 sites in United States.

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

The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
TMX-049
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
55 sitesUnited States
Study dates
10 Apr 2018to 4 Jun 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months
  • UACR 200 to 3000 mg/g
  • eGFR ≥30 ml/min/1.73m2
  • Treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both

Who cannot join

  • History of Type 1 diabetes
  • Women who are breast feeding
  • Treatment with any uric acid-lowering therapy within previous 2 weeks
  • History of intolerance to any XO (xanthine oxidase) inhibitor
  • History of a gout flare requiring pharmacologic treatment
  • History or presence of tophaceous gout
Show all 14Show fewer
  • History of immunosuppressant treatment for any known or suspected renal disorder
  • History of a non-diabetic form of renal disease
  • Glycosylated hemoglobin (HbA1c) >11%
  • sUA <4.0 mg/dL or >10.0 mg/dL
  • Positive urinary pregnancy test
  • Dialysis for acute renal failure within previous 6 months
  • Renal allograft in place or a scheduled kidney transplant within the next 22 weeks
  • Congenital or acquired solitary kidney

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Albany Medical College, Division of Community Endocinology

    Albany, New York, 12206

  • Comprehensive Research Institute

    Alhambra, California, 91801

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Community Hospital of Anderson and Madison County, Inc.

    Anderson, Indiana, 46011

  • Randolph Health Internal Medicine

    Asheboro, North Carolina, 27203

  • Nephrology Associates, PC

    Augusta, Georgia, 30901

  • Southeastern Clinical Research Institute

    Augusta, Georgia, 30909

  • Ochsner Clinic Foundation, Baton Rouge

    Baton Rouge, Louisiana, 70809

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • California Kidney Specialists

    Covina, California, 91723

  • Texas Health Physicians Group

    Dallas, Texas, 75243

  • Iowa Kidney Physicians

    Des Moines, Iowa, 50265

  • Associate in Endocrinology

    Elgin, Illinois, 60124

  • AKDHC Medical Research Services, LLC

    Flagstaff, Arizona, 86001

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Elite Research Center LLC

    Flint, Michigan, 48532

  • Endocrine Consultants of Mid Michigan

    Flint, Michigan, 48532

  • The Medical Group of Texas

    Fort Worth, Texas, 76116

  • Rockwood Medical Clinic

    Fort Worth, Texas, 76164

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Endocrine Associates

    Houston, Texas, 77004

  • Juno Research, LLC

    Houston, Texas, 77040

  • The Endocrine Center

    Houston, Texas, 77079

  • Pioneer Research Solutions INC

    Houston, Texas, 77099

  • Houston Nephrology Research

    Houston, Texas, 77429

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • Detweiler Family Medicine & Associates, PC

    Lansdale, Pennsylvania, 19446

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • My Kidney Center, LLC.

    Manhattan, Kansas, 66502

  • Solaris Clinical Research, Llc

    Meridian, Idaho, 83646

  • Aventiv Research Inc.

    Mesa, Arizona, 85210

  • Leon Medical Research

    Miami, Florida, 33015

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Endocrine Associates of Florida, P.A.

    Ocoee, Florida, 34761

  • Synexus Clinical Research US, Inc. Centennial Health, PC

    Oklahoma City, Oklahoma, 73111

  • Diabetes Associates Medical Group

    Orange, California, 92868

  • Four Rivers Clincial Research

    Paducah, Kentucky, 42003

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Pines Care Research Center

    Pembroke Pines, Florida, 33026

  • Hanson Clinical Research Center

    Port Charlotte, Florida, 33952

  • Seacost Kidney & Hypertension Specialists

    Portsmouth, New Hampshire, 03801

  • Biolab Research LLC

    Rockville, Maryland, 20852

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84108

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • BFHC Research

    San Antonio, Texas, 78249

  • California Kidney Specialists

    San Dimas, California, 91773

  • North America Research Institute

    San Dimas, California, 91773

  • Carl R. Meisner Medical Clinic, PLLC

    Sugar Land, Texas, 77478

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment.

Being tested
TMX-049, Placebo
Keywords
Diabetic Kidney Disease, XO inhibitor, UACR
Medical subject headings
Diabetic Nephropathies

What participants receive

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

  • TMX-049Drug

    A certain dose of TMX-049 to be taken orally, once daily

  • PlaceboDrug

    Matching placebo to be taken orally, once daily

Study groups in NCT03449199
Study groupRoleWhat they receive
TMX-049 40 mg QD (Once Daily)ExperimentalTMX-049: 40 mg of TMX-049 to be taken orally, once daily
Receives: Drug: TMX-049
TMX-049 200 mg QD (Once Daily)ExperimentalTMX-049: 200 mg of TMX-049 to be taken orally, once daily
Receives: Drug: TMX-049
TMX-049 PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12

    UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.

    Measured: Baseline and Week 12

Secondary outcomes (10)

  1. Changes in Estimated Glomerular Filtration Rate (GFR)

    Estimated Glomerular Filtration Rate from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured. The eGFR (estimated glomerular filtration rate) was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula based on the serum creatinine measurement.

    Measured: Baseline and Week 2, 6, 12, 16 (Follow-up)

  2. Changes in Serum Uric Acid (sUA)

    Serum Uric Acid from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured in order to explore the sUA (Serum Uric Acid) lowering effect in DKD (diabetic kidney disease) patients and the relationship between sUA and efficacy to DKD.

    Measured: Baseline and Week 2, 6, 12, 16 (Follow-up)

  3. Changes in Urinary Albumin-to-Creatinine Ratio (UACR)

    Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: Baseline and Week 2, 6, 12, 16 (Follow-up)

  4. Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio

    Changes in Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio were measured. Subject with greater than 30% reduction is estimated as responder, less than or equal to 30% reduction is estimated as non-responder.

    Measured: 16 Weeks

  5. Changes in Exploratory Blood Biomarkers (C Reactive Protein)

    Changes in Exploratory Blood Biomarkers for inflammation (C Reactive Protein) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

  6. Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)

    Changes in Exploratory Blood Biomarkers for inflammation (Soluble TNF [tumor necrosis factor] Receptor Type I) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

  7. Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)

    Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Fatty Acid Binding Protein 1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

  8. Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)

    Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Hydroxy Deoxyguanosine) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

  9. Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)

    Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Kidney Injury Molecule-1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

  10. Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)

    Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.

    Measured: 16 Weeks

Timeline

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

  1. First posted28 Feb 2018
  2. Study start10 Apr 2018
  3. Primary completion7 May 2019
  4. Study completion4 Jun 2019

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449199
Sponsor's protocol ID
TMX-049DN-201
Status last verified
Aug 2022
First submitted
9 Feb 2018
Last updated
30 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bakris GL, Mikami H, Hirata M, Nakajima A, Cressman MD. A Non-purine Xanthine Oxidoreductase Inhibitor Reduces Albuminuria in Patients with DKD: A Randomized Controlled Trial. Kidney360. 2021 Jun 30;2(8):1240-1250. doi: 10.34067/KID.0001672021. eCollection 2021 Aug 26.

    PubMed 35369650

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMX-049 in people with Diabetic Kidney Disease, run by Teijin America, Inc. at 55 sites in United States.

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 14 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. 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 1 Aug 2022). 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?

Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12 (time frame: Baseline and Week 12). 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 NCT03449199, 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 30 Aug 2022.

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