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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000014980
Enrollment
50
Registered
2014-08-28
Start date
2014-08-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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) .

Interventions

None listed

Sponsors

Department of Medicine, Kidney Center, Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 years old or more, less than 80 years old. 2) 2 days before study enrollment, the diuretics use including loop, thiazides, and/or aldosterone receptor antagonists. 3) Chronic kidney disease (eGFR < 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) exhibit systemic congestion as evidenced by jugular venous distention, pulmonary congestion, or peripheral edema. 4) Voluntarily given written informed consent.

Exclusion 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.

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

Public ContactKenichi Akiyama

Tokyo Women's Medical University Department of Medicine, Kidney Center

akiyamakenichi1982@gmail.com03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026