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

• Status: Completed
• Trial end date: 2019-06-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teijin America, Inc.

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 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