The effects of tolvaptan treatment and copeptin concentration on renal prognosis in patients with chronic kidney disease or nephrotic syndrome, who have heart failure symptoms.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000014980
• Date of registration: 28/08/2014
• Prospective Registration: No
• Primary sponsor: Department of Medicine, Kidney Center, Tokyo Women's Medical University
• Public title: The effects of tolvaptan treatment and copeptin concentration on renal prognosis in patients with chronic kidney disease or nephrotic syndrome, who have heart failure symptoms.
• Scientific title: The effects of tolvaptan treatment and copeptin concentration on renal prognosis in patients with chronic kidney disease or nephrotic syndrome, who have heart failure symptoms. - Tolvaptan treatment in patients with renal involvement and heart failure symptoms in relation to copeptin.
• Date of first enrolment: 2014/08/27
• Target sample size: 50
• Recruitment status: Pending
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017310
• Study type: Interventional,observational
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Kenichi Akiyama
• Affiliation: Tokyo Women's Medical University Department of Medicine, Kidney Center

• Name: Kosaku NItta
• Affiliation: Tokyo Women's Medical University Department of Medicine, Kidney Center

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with any mechanical support (e.g., intraaortic balloon pumping, mechanical ventilation) . 2) Patients who were suspected of having hypovolemia. 3) Patients with hemodynamically significant valvular stenosis. 4) Patients who had a history of acute coronary syndrome within 30 days before enrollment. 5) Patients with active systemic infection. 6) Patients undergoing hemodialysis or anuria. 7) Allergy to tolvaptan or tolvaptan-like compounds (e.g., mozavaptan hydrochloride) . 8) Patients cannot drink sufficient water to satisfy thirst, or does not feel thirsty. 9) Patients with hypernatremia. 10) Patients cannot drink sufficient water to satisfy thirst because of hepatic coma. 11) Patients with pregnant or who have possibility of pregnancy. 12) Patients diagnosed with autosomal dominant polycystic kidney disease. 13) Other medical condition unacceptable for entry.

Age minimum: 18years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Patients exhibit heart failure symptoms with chronic kidney disease (eGFR less than 60 mL/min/1.73 m2 for 3 months or more) or nephrotic syndrome (urinary protein excretion greater than 3.5 g/24hours, and hypoalbuminemia : less than 3.0 g/dL) .

Intervention(s)

Add oral tolvaptan 7.5 mg/day to the conventional therapy for a week.

Primary Outcome(s)

The incidence of acute kidney injury (increase in serum creatinine of 0.3 mg/dL or more within 48 hours) .

Secondary Outcome(s)

The concentration of copeptin, aquaporin2, renin, aldosteron, angiotensinogen, apelin.

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/05/2017