Unique ID issued by UMIN | UMIN000014980 |
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Receipt number | R000017310 |
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. |
Date of disclosure of the study information | 2014/08/28 |
Last modified on | 2024/03/05 09:38:49 |
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.
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.
Japan |
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) .
Medicine in general | Nephrology |
Others
NO
Safety and efficacy of tolvaptan treatment and in relation to copeptin.
Safety,Efficacy
The incidence of acute kidney injury (increase in serum creatinine of 0.3 mg/dL or more within 48 hours) .
The concentration of copeptin, aquaporin2, renin, aldosteron, angiotensinogen, apelin.
Observational
18 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
50
1st name | |
Middle name | |
Last name | Kosaku NItta |
Tokyo Women's Medical University
Department of Medicine, Kidney Center
8-1, Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
akiyamakenichi1982@gmail.com
1st name | |
Middle name | |
Last name | Kenichi Akiyama |
Tokyo Women's Medical University
Department of Medicine, Kidney Center
8-1, Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
akiyamakenichi1982@gmail.com
Department of Medicine, Kidney Center, Tokyo Women's Medical University
None
Self funding
NO
東京女子医科大学病院 (東京都)
2014 | Year | 08 | Month | 28 | Day |
Unpublished
Terminated
2014 | Year | 05 | Month | 31 | Day |
2014 | Year | 08 | Month | 27 | Day |
2014 | Year | 08 | Month | 27 | Day |
2017 | Year | 05 | Month | 31 | Day |
After the start of the test operation, the test was discontinued because the principal investigator went to study at another institution.
2014 | Year | 08 | Month | 28 | Day |
2024 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017310
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