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
Click here to add this to my saved trials
Click here to add this to my saved trials
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials