UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014980
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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.

Acronym

Tolvaptan treatment in patients with renal involvement and heart failure symptoms in relation to copeptin.

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.

Scientific Title:Acronym

Tolvaptan treatment in patients with renal involvement and heart failure symptoms in relation to copeptin.

Region

Japan


Condition

Condition

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) .

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of tolvaptan treatment and in relation to copeptin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kosaku NItta

Organization

Tokyo Women's Medical University

Division name

Department of Medicine, Kidney Center

Zip code


Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

akiyamakenichi1982@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Akiyama

Organization

Tokyo Women's Medical University

Division name

Department of Medicine, Kidney Center

Zip code


Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL


Email

akiyamakenichi1982@gmail.com


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京女子医科大学病院 (東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 28 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 05 Month 31 Day

Date of IRB

2014 Year 08 Month 27 Day

Anticipated trial start date

2014 Year 08 Month 27 Day

Last follow-up date

2017 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

After the start of the test operation, the test was discontinued because the principal investigator went to study at another institution.


Management information

Registered date

2014 Year 08 Month 28 Day

Last modified on

2024 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017310


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name