JPRN-jRCT2031200398进行中（未招募）3 期
Peritoneal dialysate TCD-58205 : A randomized double blind multicenter clinical trial
uosaki fumiyo0 个研究点目标入组 78 人开始时间: 2021年3月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subjects must meet the following criteria to be included in the study:
- •(1)Age is >= 20 years at the time of informed consent.
- •(2)Patients understand the purpose and contents and then provide a signed informed consent form by his/her own will.
- •(3)Stably receiving peritoneal dialysis at least for 3 months prior to obtaining consent.
- •(4)Receiving the same PD prescription with MIDPELIQ135/L135 or a combination of MIDPELIQ135/L135 and MIDPELIQ250/L250.
- •(5)Considered to need the removal of sodium, based on physical or laboratory findings by the investigator.
排除标准
- •Patients will be excluded from the study for:
- •(1)Receiving HD or HDF in addition to peritoneal dialysis.
- •(2)Using APD.
- •(3)PD therapy is provided once a day.
- •(4)Appropriate salt reduction management has been achieved.
- •(5)Signs of body fluid volume reduction.
- •(6)Continuous low examination room systolic blood pressure and considered ineligible for the study by the investigator.
- •(7)Symptomatic orthostatic hypotension.
- •(8)Serum sodium concentration less than 130mEq or having symptomatic hyponatremia.
- •(9)Suspected peritoneal deterioration.
- •(10)Severe hypoproteinemia or severe obesity or poor dietary intake.
- •(11Peritonitis within 3 months prior to obtaining consent.
- •(12)Severe exit-site infections or tunnel infection.(13)Poor drainage due to catheter trouble.
- •(14)Straight after abdominal surgery or peritoneal injury or peritoneal adhesion or intra-abdominal organ disease.
- •(15)Parathyroidectomy within 3 months prior to the informed consent.
- •(16)Serious disease of liver, heart, lung, etc. or hematologic disorder.
- •(17)Cancer and other serious diseases.
- •(18)WIth the artificial anus.
- •(19)Currently pregnant, lactating mother or planning to become pregnant during the course of the study.
- •(20)Addition of diuretics or antihypertensive agents or change in dosage and administration within 30 days prior to obtaining consent
- •(21)HBV, HCV or HIV.
- •(22)Difficulty in drug management under the direction of the investigator or Needed Support/Need for Long-Term Care condition
- •(23)Current participation in clinical study that has not completed primary endpoint evaluation or studies that may have an impact on the evaluation of this clinical trial.
- •(24)Considered ineligible for the study by the investigator.
研究者
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