NCT01895322已完成2 期
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change in Daily Urine Volume From Baseline
研究概览
简要总结
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic renal failure
- •Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])
- •Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect:
- •Addition or increase of diuretics
- •Increase in concentration or volume of peritoneal dialysis fluid
- •Increase in the number of changes of peritoneal dialysis fluid
- •Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration
- •Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
排除标准
- •Subjects with any of the following diseases, complications, or symptoms:
- •Suspected hypovolemia
- •Daily urine volume less than 200 mL
- •Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- •Cardiac function of NYHA class 4
- •Subjects with any of the following medical histories:
- •History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
- •History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
- •Subjects with any of the following abnormal laboratory values:
- •Hemoglobin lower than 9.0 g/dL, total bilirubin higher than 3.0 g/dL, ALT (GPT) or AST (GOT) 2 times the upper limit of the reference range of the trial site, serum sodium higher than the upper limit of the reference range of the trial site, serum sodium lower than 125 mEq/L, or serum potassium higher than 5.5 mEq/L
- •Subjects with any of the following conditions, concomitant diseases, or symptoms:
- •defect in diaphragm
- •hemorrhagic diathesis due to uremia
- •suspected lactic acid metabolic disorder
- •suspected peritonitis, peritoneal damage, peritoneal adhesion, or disorders in intraabdominal organs
- •Subjects who have undergone peritoneal dialysis for 8 years or longer
- •Subjects who are scheduled to undergo hemodialysis or concomitant use of hemodialysis, or renal transplantation
- •Subjects who have participated in any other clinical trial or post-marketing clinical studies within 30 days prior to informed consent
- •Subjects who have previously received OPC-41061
- •Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
- •Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period
- •Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
研究组 & 干预措施
OPC-41061
Experimental
干预措施: OPC-41061 (Drug)
结局指标
主要结局
Change in Daily Urine Volume From Baseline
时间窗: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Percent Change in Daily Urine Volume From Baseline
时间窗: 100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
次要结局
- Percent Change in Body Weight(100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>)
- Change in Body Weight From Baseline(Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period)
研究者
相似试验
已完成
2 期
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or HemodiafiltrationChronic Renal FailureNCT01876381Otsuka Pharmaceutical Co., Ltd.26
已完成
2 期
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or HemodiafiltrationChronic Renal FailureNCT02331680Otsuka Pharmaceutical Co., Ltd.124
已完成
3 期
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)Cardiac EdemaNCT00544869Otsuka Pharmaceutical Co., Ltd.52
终止
1 期
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple MyelomaMultiple Myeloma (MM)NCT04649073Otsuka Pharmaceutical Co., Ltd.11
未知
3 期
A clinical phamacological study of OPC-41061 in the treatment of cardiac edema (congestive heart failure)Cardiac edema (CHF)JPRN-jRCT2080220442Otsuka Pharmaceutical Co., Ltd.