NL-OMON51892撤回3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease - CLARION-CKD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subject must be *18 years of age at the Screening Visit (Visit 1).
- •* Body mass index (BMI) must be *19 to <45 kg/m2at the Screening Visit
- •(Visit 1).
- •* Subject must have uncontrolled hypertension defined as meeting both of the
- •following criteria:
- •- The subject has a resting seated trough cuff SBP *140 mm Hg at the Screening
- •Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In
- •- The subject is taking 2 or more antihypertensive medications that have been
- •titrated upward as tolerated to hypertension target doses per local SoC and
- •have been stable (i.e., without any dose adjustments) from 4 weeks before the
- •Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3).
- •* The antihypertensive medications must include at least 1 loop, thiazide, or
- •thiazide-like diuretic unless the subject has a documented intolerance to or
- •contraindication for diuretic therapy.
- •* A subject on 1 antihypertensive medication that has been titrated upward as
- •tolerated to a hypertension target dose per local SoC and has been stable
- •during the 4 weeks prior to the Screening Visit (Visit 1) may be enrolled in
- •the study if the subject has a documented history of intolerance to multiple
- •antihypertensive medications.
- •* The subject must have Stage 3b (eGFR *30 and *44 mL/min/1.73 m2) or Stage 4
- •(eGFR *15 and <30 mL/min/1.73 m2) CKD.
排除标准
- •Subject has a serum potassium level >4.8 mmol/L according to central
- •laboratory results during the Screening or Run-In Periods.
- •* Subject has had a serum potassium level >5.6 mmol/L within 2 weeks before
- •the Screening Visit (Visit 1).
- •* Subject has been hospitalization for hyperkalemia within the 3 months before
- •the Randomization Visit (Visit 3).
- •* Subject was not compliant with taking placebo during the Run-in Period
- •(defined as taking <80% or >120% of planned placebo doses) or the
- •Investigator determines that the subject was not compliant with background
- •antihypertensive medications during the Run-in Period as assessed at the
- •Randomization Visit (Visit 3).
- •* Subject has taken an MRA, a potassium-sparing diuretic, or chronic potassium
- •supplements during the 4 weeks before the Screening Visit (Visit 1).
- •* Subject has taken potassium binders for the treatment of hyperkalemia during
- •the 3 months before the Screening Visit (Visit 1).
- •* Subject has taken a strong CYP3A4 inducer or strong CYP3A4 inhibitor during
- •the 7 days before the Randomization Visit (Visit 3).
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856EUCTR2018-003985-15-PTArena Pharmaceuticals Inc.433
进行中（未招募）
1 期
A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisEUCTR2019-000968-18-CZCB Biopharma SR240
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyHomologous recombination deficiency advanced ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000952-11-ITTESARO, INCORPORATED733
进行中（未招募）
1 期
A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)EUCTR2016-004148-13-PTGilead Sciences, Inc.800
招募中
1 期
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung Cancerung Cancer, Non-Small CellMedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-508443-40-00Glaxosmithkline Research & Development Limited644