NCT03449199已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 54
- 主要终点
- Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TMX-049 200 mg QD (Once Daily)
Experimental
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
干预措施: TMX-049 (Drug)
TMX-049 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TMX-049 40 mg QD (Once Daily)
Experimental
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
干预措施: TMX-049 (Drug)
结局指标
主要结局
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
时间窗: Baseline and Week 12
UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
次要结局
- Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio(16 Weeks)
- Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)(16 Weeks)
- Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)(16 Weeks)
- Changes in Estimated Glomerular Filtration Rate (GFR)(Baseline and Week 2, 6, 12, 16 (Follow-up))
- Changes in Urinary Albumin-to-Creatinine Ratio (UACR)(Baseline and Week 2, 6, 12, 16 (Follow-up))
- Changes in Exploratory Blood Biomarkers (C Reactive Protein)(16 Weeks)
- Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)(16 Weeks)
- Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)(16 Weeks)
- Changes in Serum Uric Acid (sUA)(Baseline and Week 2, 6, 12, 16 (Follow-up))
- Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)(16 Weeks)
研究者
研究点 (54)
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