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Completed

NCT Number: NCT03449199

Phase 2 Study 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.

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Key information

Conditions

Diabetic Kidney Disease 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AKDHC Medical Research Services, LLC, Flagstaff, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

TMX-049

Drug

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

Placebo

Drug

Matching placebo to be taken orally, once daily

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

  1. Changes in Estimated Glomerular Filtration Rate (GFR)

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

    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.

  2. Changes in Serum Uric Acid (sUA)

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

    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.

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

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

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

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

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

    Time frame: 16 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Teijin America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Aug 30, 2022

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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