TCD-58205

JRCT ID: jRCT2031200398

Registered date:05/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with chronic renal failure on peritoneal dialysis
• Date of first enrollment: 05/03/2021
• Target sample size: 78
• Study type: Interventional
• Intervention(s): Intraperitoneal administration of the TCD-58205(1500mL or 2000mL) once or twice a day

Outcome(s)

• Primary Outcome: Amount of change in transperitoneal sodium removal per day from baseline at visit 2 of the second period.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: uosaki fumiyo