EUCTR2021-003636-88-ES进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •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 Period.
- •- 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.
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 405
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
Efficacy and safety of Cabozantinib (XL184) in subjects who have progressed after VEGFR-targeted treatmentRadioiodine-Refractory Differentiated Thyroid Cancer which has progressed after priorVEGFR-targeted therapyMedDRA version: 20.0Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001771-21-CZExelixis, Inc.300
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）
不适用
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of 48 Weeks of GS-9190 in Combination with Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Previously Untreated Subjects with Genotype-1 Chronic Hepatitis C Virus (HCV) InfectioEUCTR2009-013442-86-BEGilead Sciences Inc560
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