NCT05786443招募中2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Total Body Water from Baseline to 12 Weeks
研究概览
简要总结
A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function
- •Thrice-weekly HD
- •Willingness and capacity to provide informed consent
- •For women of childbearing potential, a negative pregnancy test is required at screening
排除标准
- •Does not have capacity to consent
- •Anuria (daily urine volume < 200 mL/day)
- •Planned kidney transplant within 3 months
- •Recurrent urinary tract infections (>2 episodes/year or antibiotic prophylaxis)
- •New York Heart Association (NYHA) Class IV heart failure (HF)
- •Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
- •History of diabetic ketoacidosis
- •Type 1 Diabetes Mellitus
- •Hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN, unless consistent with Gilbert's disease
- •Active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative.
- •Major surgery within 12 weeks
- •Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
- •Combination use of angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB)
- •Current use of an SGLT2 inhibitor (within 6 weeks prior to randomization)
- •Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
- •Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
- •Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
- •Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy.
- •Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
研究组 & 干预措施
Empagliflozin
Experimental
Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.
干预措施: Empagliflozin 10 MG (Drug)
Placebo
Placebo Comparator
Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Body Water from Baseline to 12 Weeks
时间窗: Baseline, Week 12
Change in Extracellular Volume from Baseline to 12 Weeks
时间窗: Baseline, Week 12
Extracellular volume is the sum of the plasma volume and interstitial fluid volume.
Change in Intracellular Volume from Baseline to 12 Weeks
时间窗: Baseline, Week 12
Intracellular volume is the fluid content within the body's cells.
Change in 24-Hour Urine Volume from Baseline to 12 Weeks
时间窗: Baseline, Week 12
Urine volume over a 24-hour period.
次要结局
- Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks(Baseline, Week 12)
- Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks(Baseline, Week 12)
- Change in Heart Rate Variability from Baseline to 12 Weeks(Baseline, Week 12)
- Incidence of Intra-Dialytic Hypotension(Up to Week 12)
- Incidence of Inter-Dialytic Hypotension(Up to Week 12)
- Incidence of Serious Hypotension(Up to Week 12)
- Incidence of Non-Serious Hypoglycemia(Up to Week 12)
- Incidence of Serious Hypoglycemia(Up to Week 12)
- Incidence of Ketoacidosis(Up to Week 12)
- Number of Adverse Events(Up to Week 12)
- Number of Serious Adverse Events(Up to Week 12)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
GB001 in Adult Participants With Chronic RhinosinusitisChronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)NCT03956862GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.97
终止
2 期
A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based TherapyUrothelial CarcinomaNCT03029832Genentech, Inc.5
已完成
2 期
Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney DiseaseChronic Kidney DiseasesHypertensionNCT03574363KBP Biosciences162
已完成
2 期
To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPFIdiopathic Pulmonary FibrosisNCT05483907Bridge Biotherapeutics, Inc.129
已完成
2 期
A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)Plaque PsoriasisNCT04855721Aurigene Discovery Technologies Limited141