Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | April 10, 2018 |
| End Date: | June 30, 2019 |
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
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.
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.
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
We found this trial at
47
sites
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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