EUCTR2016-002657-38-HR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients with Resistant Hypertension and Chronic Kidney Disease: Evaluation of Safety and Efficacy (AMBER) - Spironolactone with Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
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
- Relypsa, Inc
- 入组人数
- 290
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
- •Eligible subjects must meet all the following criteria:
- •1. Provide written informed consent prior to participation in the study
- •2. Age = 18 years
- •3. Taking at least three antihypertensive medications, one of which is a diuretic, for at least 28 days at a stable dose. ACE inhibitors or ARBs should be included among these three antihypertensive medications, unless previously not tolerated or contraindicated.
- •4. Uncontrolled hypertension as documented by AOBP SBP 135 to 160 mmHg at each Screening Visit; however, AOBP SBP may be < 135 mmHg at either S2 or S3 Visits
- •5. eGFR of 25 – = 45 mL/min/1.73 m2 (mean [calculated by the IWRS] of two values measured at S1 and S3 or 7 to 28 days apart during the Screening/Run-in and calculated using CKD Epidemiology Collaboration [CKD-EPI] formula)
- •6. Qualifying local laboratory K+ measurements of 4.3 – 5.1 mEq/L obtained at Visits S1, S3 and S4 (all measurements must be within range)
- •7. Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, must use a medically acceptable form of birth control from 28 days prior to screening through the study and for 28 days after completion of the study
- •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 174
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 116
排除标准
- •Subjects must not meet any of the following criteria:
- •1. History of untreated secondary causes of hypertension (other than CKD) including but not limited to Cushing’s syndrome, primary hyperaldosteronism, renal vascular stenosis, or coarctation of the aorta
- •2. Inability to measure BP (e.g., the largest sized arm BP cuff is inadequate given the circumference of the subject’s arm)
- •3. Noncompliance with antihypertensive medications, in the investigator’s judgment
- •4. Change in renal function requiring hospitalization or dialysis within 3 months prior to screening
- •5. Renal transplant or anticipated need for renal transplantation during planned study participation
- •6. History of malignancy within the previous 12 months except for cured non-melanocytic skin cancer
- •7. Recent cardiovascular event (within the last 3 months): myocardial infarction, unstable angina, hospitalization for heart failure, revascularization, or stroke (or transient ischemic attack)
- •8. Clinically significant ventricular arrhythmia
- •9. Atrial fibrillation with HR > 100 bpm
- •10. Previous use of patiromer in a clinical study
- •11. Any current use of spironolactone or other mineralocorticoid antagonists (e.g., eplerenone)
- •12. Hypersensitivity to patiromer, spironolactone, or any of their components
- •13. Use of any of the following permitted potassium-altering chronic medications if doses have not been stable for at least 28 days prior to screening or if doses are anticipated to change during study participation: bronchodilators, theophylline, heparin, and canagiflozin
- •14. Use of the following prohibited medications within 7 days prior to Screening: calcium acetate or calcium carbonate supplements (unless for occasional antacid use, at the discretion of the Investigator), digoxin, direct renin inhibitors (e.g., aliskiren), lanthanum carbonate, lithium, sevelamer, quinidine, sodium polystyrene sulfonate or calcium polystyrene sulfonate, colesevelam, colestipol, cholestyramine, drospirenone, potassium supplements, bicarbonate or baking soda (unless for occasional antacid use, at the discretion of the Investigator), triamterene, amiloride, trimethoprim, tacrolimus, cyclosporine, systemic glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (with the exception of low dose aspirin), sympathomimetics
- •15. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening
- •16. History of bowel obstruction, swallowing disorders, clinically significant gastroparesis, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., large bowel resection)
- •17. Inability to take the study medications or comply with the protocol, in the opinion of the Investigator
- •18. History of alcohol or drug abuse within 1 year of screening
- •19. Any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or affect the validity of the trial results, in the opinion of the Investigator
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