EUCTR2021-001434-19-IT进行中（未招募）1 期
Randomised, double-blind, placebo-controlled and parallel dose group trialto investigate efficacy and safety of multiple doses of oral BI 690517 over14 weeks, alone and in combination with empagliflozin, in patients withdiabetic and non-diabetic chronic kidney disease - Phase II dose finding/PoCC in CKD
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 552 人开始时间: 2021年11月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 552
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. Signed and dated written informed consent in accordance with ICHGCP
- •and local legislation prior to admission to the trial.
- •2. Male or female patients aged = 18 years at time of consent.
- •3. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]
- •formula) = 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory
- •4. UACR = 200 and < 5,000 mg/g in spot urine (midstream urine
- •sample) by central laboratory analysis at Visit 1.1
- •5. If the patient is taking any of the following medications they should
- •be on a stable dose for at least 4 weeks prior to visit 1 and until first
- •randomisation prior to run-in with no planned change of the therapy
- •during the trial: anti-hypertensives, NSAIDs, endothelin receptor
- •antagonists, low dose systemic steroids (e.g. prednisolone =10 mg or
- •equivalent).
- •6. Treatment with a clinically appropriate, stable dose of either ACEi or
- •ARB (but not both together), for = 4 weeks prior to visit 1 and until first
- •randomisation with no planned change of the therapy during the trial.
- •7. In the Investigator's opinion, one or more of the following underlying
- •kidney disease causes:
- •-- Diabetic kidney disease. These patients must have type 2 diabetes
- •mellitus and their treatment (including GLP1 receptor agonist) should be
- •unchanged or changes deemed minor (according to investigator's
- •judgement) within 4 weeks prior to Visit 1 and until first randomisation.
- •-- Hypertensive kidney disease
- •-- Chronic glomerulonephritis defined as one of the following:
- •o IgA nephropathy,
- •o Membranous nephropathy
- •o Focal Segmental Glomerulosclerosis (FSGS)
- •8. Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the
- •central laboratory.
- •9. Serum potassium = 4.8 mmol/L at Visit 1 measured by the central
- •laboratory.
- •10. Seated SBP = 110 and = 160 mmHg and DBP = 65 and = 110 mmHg
- •at Visit 1 (mean values from three BP measurements) and optimised
- •anti-hypertensive treatment according to local standard of care and
- •investigator's judgement.
- •11. Body Mass Index (BMI) = 18.5 and < 50 kg/m2 at Visit 1.
- •12. Women of child-bearing potential2 (WOCBP) must be ready and able
- •to use highly effective methods of birth control. Such methods should be
- •used throughout the trial. Men must be vasectomised or willing and able
- •to use a condom if their partner is a WOCBP.
- •Additional inclusion criteria to be assessed before second randomisation
- •(start of Treatment Period):
- •1. Serum potassium = 4.8 mmol/L measured by local or central
- •laboratory within 7 days prior to randomisation to the Treatment Period.
- •2. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]
- •formula) = 20 mL/min/1.73 m2 measured by local or central laboratory
- •within 7 days prior to randomisation to the Treatment Period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •1. Treatment with inhibitors of aldosterone mediated effects (e.g.,
- •mineralocorticoid receptor antagonists such as spironolactone), or
- •intake of other potassium sparing
- •diuretics (e.g., amiloride) within 7 days prior to first randomisation or
- •planned during trial treatment phase.
- •2. Treatment with other Renin Angiotensin Aldosterone System (RAAS)
- •interventions (apart from either ACEi or ARB) within 4 weeks prior to
- •Visit 1 and throughout screening or planned during the trial.
- •3. Type 1 diabetes mellitus, or history of other autoimmune causes of
- •diabetes mellitus (e.g. LADA)
- •4. Patients at increased risk of ketoacidosis in the opinion of the
- •investigator.
- •5. Currently receiving SGLT-2 or SGLT-1/2 inhibitor or planned initiation
- •during the trial.
- •Further criteria apply.
研究者
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