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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Kidney Disease

In brief

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.

Key facts

Study ID

NCT03449199

Run by

Teijin America, Inc.

People needed

130

Starts

2018-04-10

Expected to finish

2019-06-04

Last updated by the study team

2022-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aventiv Research Inc. — Mesa, Arizona, United States
• Comprehensive Research Institute — Alhambra, California, United States
• California Kidney Specialists — Covina, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Diabetes Associates Medical Group — Orange, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• California Kidney Specialists — San Dimas, California, United States
• North America Research Institute — San Dimas, California, United States
• Leon Medical Research — Miami, Florida, United States
• San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
• Endocrine Associates of Florida, P.A. — Ocoee, Florida, United States
• Pines Care Research Center — Pembroke Pines, Florida, United States
• Hanson Clinical Research Center — Port Charlotte, Florida, United States
• Nephrology Associates, PC — Augusta, Georgia, United States
• Southeastern Clinical Research Institute — Augusta, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Solaris Clinical Research, Llc — Meridian, Idaho, United States
• Associate in Endocrinology — Elgin, Illinois, United States
• Community Clinical Research Center — Anderson, Indiana, United States
• Community Hospital of Anderson and Madison County, Inc. — Anderson, Indiana, United States
• Iowa Kidney Physicians — Des Moines, Iowa, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• My Kidney Center, LLC. — Manhattan, Kansas, United States
• AKDHC Medical Research Services, LLC — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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