EUCTR2012-005848-21-DK进行中（未招募）1 期
A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan - SONAR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject has type 2 diabetes (including patients with latent autoimmune diabetes or insulin-treated patients without a history of diabetic ketoacidosis who also have a negative anti-glutamic acid decarboxylase test AND an elevated post-prandial serum C-peptide level) and has been treated with at least one anti-hyperglycemic medication and ACEi/or ARB (RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit.
- •2. For entry into the Run-In Period the subject must satisfy the following criteria based on the Screening laboratory values:
- •Estimated GFR 25 to 75 mL/min/1.73 m2 [until the eGFR cap on subjects (approximately 300) with a baseline of > 60 mL/min/1.73 m2 is reached] and a UACR = 300 and < 5,000 mg/g (= 34 mg/mmol and < 565 mg/mmol);
- •Serum albumin = 2.5 g/dL (25 g/L);
- •BNP = 200 pg/mL (200 ng/L);
- •Serum Potassium = 3.5 (3.5 mmol/L) and = 6.0 mEq/L (6.0 mmol/L);
- •SBP = 110 and = 180 mmHg at any time during the Screening Period;
- •Subjects on a MTLDD of a RAS inhibitor for = 4 weeks and on a diuretic at the time of screening and who satisfy the above criteria may proceed directly to the last visit in Run-In Period (R6 visit);
- •Subjects on a MTLDD of a RAS inhibitor for = 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening will start with a diuretic and participate in Run-In for at least 2 weeks.
- •4. For entry into the Enrichment Period the subject must satisfy the following criteria based on the last visit of the Run-In Period:
- •RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose;
- •Subjects that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks.
- •5. For entry into the Double-Blind Treatment Period, the subject must satisfy the following criteria based on the last visit of the Enrichment Period:
- •Subject has taken a RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;
- •Subject has taken a diuretic at any dose unless medically contraindicated or clinically intolerable in the investigator's judgement (i.e., hypotension or hypokalemia);
- •Subject must not have a weight change = 3 kg from the beginning of Enrichment (E1) to the end of the Enrichment Period and absolute serum BNP = 300 pg/mL (300 ng/L) at the last Enrichment visit;
- •Subject must not have an increase in serum creatinine > 0.5 mg/dL and > 20% increase from the beginning of Enrichment (E1) to the end of the Enrichment Period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2656
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2844
排除标准
- •Subject has a history of severe peripheral edema or facial edema requiring diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial Screening S1 visit.
- •Subject has a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).
- •Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
- •Subject has known non-diabetic kidney disease (other than kidney stones).
- •Subject has elevated liver enzymes (serum alanine aminotransaminase [ALT] and/or serum aspartate aminotransaminase [AST]) > 3 × the upper limit of normal (ULN).
- •Subject is currently receiving rosiglitazone, moxonidine, aldosterone blockers, aliskiren, or a combination of ACEi and ARB.
研究者
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