EUCTR2012-005848-21-NL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
- 5,107
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
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:
- •Screening laboratory values:
- •? Estimated GFR 25 to 75 mL/min/1.73 m2 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 mEq/L (3.5 mmol/L) = 6.0 mEq/L (6.0 mmol/L); and
- •? 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 the Run-In Period (R6 visit).
- •Subjects on a MTLDD RAS inhibitor for = 4 weeks and not on a diuretic (unless medically contra-indicated) at the time of Screening will start with a diuretic and participate in Run-In for at least 2 weeks.
- •3. For entry into the Enrichment Period, the subject must satisfy the following criteria:
- •Based on the last visit of the Run-In Period:
- •? Subject received a RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose;
- •? Subject was on a MTLDD RAS inhibitor and not on a diuretic (unless
- •medically contra-indicated) at the time of Screening and has been in Run-In for at least 2 weeks.
- •For entry into the Double-Blind Treatment Period, the subject must satisfy the
- •following criteria:
- •7. Based on his/her 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 judgment (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
- •(> 48 umol/L) 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 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4700
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 or 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
- •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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