Status:
COMPLETED
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
Lead Sponsor:
Teijin America, Inc.
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03449199
Start Date
April 10 2018
End Date
June 4 2019
Last Update
August 30 2022
Active Locations (55)
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1
AKDHC Medical Research Services, LLC
Flagstaff, Arizona, United States, 86001
2
Aventiv Research Inc.
Mesa, Arizona, United States, 85210
3
Comprehensive Research Institute
Alhambra, California, United States, 91801
4
California Kidney Specialists
Covina, California, United States, 91723