EUCTR2021-001434-19-ES进行中（未招募）1 期
Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease - Phase II dose finding/PoCC in CKD
Boehringer Ingelheim España S.A.0 个研究点目标入组 552 人开始时间: 2021年12月17日最近更新:
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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 ICH-GCP 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 analysis.
- •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
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 252
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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