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

Teijin

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: Placebo; Drug: TMX-049

Study type: Interventional

Funder types: Industry

Identifiers

NCT03449199

TMX-049DN-201

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 3 patient groups, including a placebo group

TMX-049 40 mg QD (Once Daily)

Experimental group

Description:

TMX-049: 40 mg of TMX-049 to be taken orally, once daily

Treatment:

Drug: TMX-049

TMX-049 200 mg QD (Once Daily)

Experimental group

Description:

TMX-049: 200 mg of TMX-049 to be taken orally, once daily

Treatment:

Drug: TMX-049

TMX-049 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo