EUCTR2019-003297-53-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of individually titrated oral doses of runcaciguat in subjects with clinical diagnosis of chronic kidney disease with diabetes and/or hypertension and at least one cardiovascular comorbidity - CONCORD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 432
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. Participant must be = 45 of age inclusive, at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2. Participants who have:
- •history of any of the following:
- •- type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose-lowering medications and/or insulin) for at least 2 years, and/or
- •- diagnosis of hypertension (defined as systolic blood pressure [BP] values = 140 mmHg and/or diastolic BP values =90 mmHg) and on hypertension medication for at least 5 years
- •established atherosclerotic cardiovascular disease (e.g. coronary artery disease, peripheral arterial disease, cerebrovascular disease) or heart failure
- •a clinical diagnosis of CKD based on all of the following criteria:
- •- (estimated) glomerular filtration rate (eGFR) = 25 mL/min/1.73 m2 but = 60 mL/min/1.73 m2 (acc. Percentage of decrease in eGFR [CKD EPI])
- •- persistent high albuminuria defined as urine albumin-to-creatinine ratio [UACR] of between 30 mg/g and 3000 mg/g in 2 first morning void samples (collected at least 1 week apart)
- •- Stable treatment with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB) for the participant maximum tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization, without any adjustments to this therapy for at least 4 weeks prior to randomization.
- •Diabetes patients that are on SGLT2-inhibitor (SGLT: sodium glucose transport protein) have to be on stable treatment for at least 3 months before Screening visit.
- •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 216
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 216
排除标准
- •Medical Conditions
- •1. Known non-diabetic and non-hypertension related renal diseases as autosomal dominant polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, IgA nephropathy without hypertension, or any other secondary glomerulonephritis
- •2. Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association (NYHA class III - IV)
- •3. Uncontrolled hypertension indicated by >160 mmHg systolic BP or =100 mmHg diastolic BP
- •4. History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma).
- •5. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 3 months prior to the planned randomization
- •6. Dialysis for acute renal failure within the previous 6 months prior to the planned randomization
- •7. Renal allograft in place or a scheduled kidney transplant within the next 18 weeks (being on a waiting list does not exclude the subject)
- •8. Hepatic insufficiency classified as Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. aspartate aminotransferase [AST] or Alanine aminotransferase [ALT] >3x upper limit of norm [ULN]).
- •9. Active malignancy other than treated squamous cell, carcinoma in situ, or basal cell carcinoma of the skin
- •Prior/Concomitant Therapy
- •10. Non diabetic patients treated with SGLT-2 inhibitors
- •11. Combination use of ACEi and ARB within 3 months prior to randomization
- •12. Concomitant therapy with nitrates, PDE5 inhibitors including non-specific inhibitors (e.g. dipyridamole and theophylline), soluble guanylate cyclase [sGC] stimulators, renin inhibitors (within 4 weeks prior to randomization)
- •13. Participation in another clinical study or treatment with another investigational product 90 days prior to randomization
- •14. Previous randomization in this study
- •Diagnostic Assessments
- •15. HbA1c >11%
研究者
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