Phase 2 N=130 Randomized Quadruple-blind Treatment

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

Diabetic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT03449199 ↗

Enrolled (actual)

130

Serious AEs

7.7%

Results posted

Aug 2022

Primary outcome: Primary: Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12 — -0.10; -0.15; -0.53 Log(mg/g) — p=0.7953

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TMX-049 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Teijin America, Inc.
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12	-0.10; -0.15; -0.53	0.7953
SECONDARY Changes in Estimated Glomerular Filtration Rate (GFR)	-0.02; 0.98; 0.18; -1.41; -1.06; 0.00	0.4055
SECONDARY Changes in Serum Uric Acid (sUA)	-0.03; -2.57; -3.54; -0.22; -2.54; -3.34	<0.0001 sig
SECONDARY Changes in Urinary Albumin-to-Creatinine Ratio (UACR)	25.44; 53.88; -86.20; -81.90; -30.37; -86.12	0.3955
SECONDARY Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio	10; 14; 19; 32; 29; 25	0.2791
SECONDARY Changes in Exploratory Blood Biomarkers (C Reactive Protein)	0.046; 0.014; 0.087; -0.011; 0.003; -0.084	—
SECONDARY Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)	-13.7; -92.3; 38.7; -77.1; 47.6; 60.7	—
SECONDARY Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)	0.03; 0.01; -0.04; -0.04; 0.04; -0.04	—
SECONDARY Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)	1.47; 4.70; 6.08; 1.72; 3.22; 4.88	—
SECONDARY Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
SECONDARY Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)	-0.01; 0.03; -0.01; 0.02; 0.02; -0.02	—

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). 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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03449199). 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.