EUCTR2019-001579-35-HU进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Pharmacokinetics of KBP-5074 in Patients with Moderate-to-Severe Chronic Kidney Disease and Uncontrolled Hypertension – (BLOCK/CKD) - BLOCK/CKD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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.Male or female, between 18 and 85 years of age, inclusive. The lower age limit may be higher if it is legally required in the participating country;
- •2.Body mass index between 19 and 45 kg/m2, inclusive;
- •3.Stage 3B/4 CKD (defined as eGFR = 15 and = 44 mL/min/1.73 m2, based on the isotope dilution mass spectrometry traceable MDRD equation version 4, according to central laboratory results at Screening;
- •4. Uncontrolled hypertension (Grade 1 to 2 systolic hypertension – ESC/ESH), defined as:
- •- Resting trough cuff seated SBP = 140 and = 179 mmHg based on the mean of at least 2 current consecutive clinic blood pressure readings at Screening and at the end of the placebo run-in period (Visit 3); AND
- •- Currently on 2 or more antihypertensive medications, which have been titrated upward as tolerated to recommended hypertension target doses (such as diuretics [except for potassium-sparing diuretics], renin angiotensin system blockers, and/or calcium channel blockers. One of the antihypertensive medications must be high ceiling diuretic (loop or thiazide like), unless there is a documented intolerance or contraindication to diuretic therapy. The doses of the antihypertensive medications should be stable without any dose adjustment during the 30 days prior to randomization; OR
- •- Patients with uncontrolled hypertension and moderate-to-severe CKD with documented history of intolerance to multiple antihypertensive medications on fewer than 2 antihypertensive medications;
- •5. Serum potassium = 4.8 mmol/L at both Screening and the end of the placebo run-in period. A single retest is allowed to exclude laboratory error or hemolyzed samples;
- •6.Women of childbearing potential (WOCBP) must agree to use 2 medically accepted, effective methods of birth control during the study and for 90 days after the end of the study. Adequate methods of contraception are defined as those that result in a low failure rate (< 1% per year) when used consistently and correctly.
- •- WOCBP are defined as women who are not surgically or chemically sterilized, including hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable), and who are between menarche and 1-year post-menopause; and
- •- Post-menopausal is defined as amenorrheic for at least 1 year, AND if aged under 60 years, have a serum follicle-stimulating hormone (FSH) level > 20 mIU/L. Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (eg, age appropriate and history of vasomotor symptoms);
- •7.Males with partners who are WOCBP must agree to use condoms plus spermicide and their female partner must also be using contraception (eg, hormonal or intra-uterine device). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug;
- •8. Males must also refrain from donating sperm during the study and for 90 days after the last dose;
- •9.Capable of understanding the written informed consent, provide signed and witnessed written informed consent before any study-specific procedure, and agree to comply with protocol requirements.
- •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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for
排除标准
- •1. Resting trough cuff seated SBP = 180 or < 140 mmHg, based on the mean of at least 2 current consecutive clinic blood pressure readings at Screening and the end of the placebo run-in period;
- •2. Serum potassium > 4.8 mmol/L;
- •3. Compliance with medications < 80% or > 120% during the run-in period;
- •4. Currently on an MRA other than KBP-5074 or received any MRAs during the last 3 months prior to Screening or currently on any potassium supplements;
- •5. Chronic or intermittent use of a potassium binder for the treatment of hyperkalemia from 3 months prior to Screening until the end of study assessments;
- •6. Have routinely or chronically used or required potassium-sparing diuretics within 3 months prior to Screening until the end of study assessments;
- •7. History of known/suspected contraindications, allergy, or intolerance to MRAs or has a known hypersensitivity to KBP-5074, other MRAs or related compounds;
- •8. Clinically significant hyperkalemia while on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, direct renin inhibitor and/or MRA, requiring down titration or discontinuation of above medication, or hospitalization for hyperkalemia within 3 months prior to Screening, or hyperkalemia > 5.6 mmol/L during the 2 weeks prior to Screening;
- •9. History/diagnosis of renal artery stenosis or history/diagnosis of renovascular hypertension;
- •10. Currently receiving HD, or peritoneal dialysis within 3 months prior to Screening, and those patients with an episode of acute kidney injury within 3 months of Screening;
- •11. History of a renal transplant, or impending renal transplant;
- •12. Acute decompensated heart failure including exacerbation of chronic heart failure manifested by signs and symptoms that may require hospitalization and/or intravenous diuretic therapy within 3 months prior to Screening, or presence of hemodynamically significant valve diseases and/or other hemodynamically significant obstructive lesions of left ventricular outflow tract;
- •13. Major cardiac, cerebral, and/or carotid artery diseases within 6 months prior to Screening; OR Cardiovascular conditions likely to require surgical or percutaneous intervention within 6 months from Screening;
- •14. History of clinically significant arrhythmia, including but not limited to any of the following:
- •-Symptomatic bradycardia and/or symptomatic ventricular arrhythmia within 3 months prior to Screening
- •- Second- or third-degree heart block or New onset or untreated atrial fibrillation
- •15. QT interval corrected using Fridericia’s formula (QTcF) > 450 ms for males or > 470 ms for females at Screening or Day 1; QTcF should be the average of the required triplicate set of ECGs at each timepoint
- •16. History of prolonged QT interval;
- •17. History or family history of sudden cardiac death or long QT syndrome;
- •18. History of cardiac transplant, on a heart transplant list, or has a left ventricular assistance device;
- •19. History of clinically significant acute or chronic hepatitis, hepatocirrhosis, or hepatic tumors;
- •20. History of gastrointestinal surgery that might affect absorption/oral bioavailability of oral antihypertensive therapies including KBP-5074;
- •21. Clinically significant abnormal liver function test at Screening or the end of the run-in period;
- •22. Positive blood screen for HIV, hepatitis B surface antigen, or hepatitis C virus antibody;
- •23. History of malignancy in the past 5 years, with the exception of basal or resected cutaneous squamous ce
研究者
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