UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012006
Receipt number R000014031
Scientific Title The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease: A multicenter, randomized, open label, blind endpoint study (AQUAKID-Study)
Date of disclosure of the study information 2013/10/09
Last modified on 2014/04/16 16:40:33

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Basic information

Public title

The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease: A multicenter, randomized, open label, blind endpoint study (AQUAKID-Study)

Acronym

The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease

Scientific Title

The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease: A multicenter, randomized, open label, blind endpoint study (AQUAKID-Study)

Scientific Title:Acronym

The efficacy of tolvaptan in a population with congestive heart failure and chronic kidney disease

Region

Japan


Condition

Condition

congestive heart failure and chronic kidney disease

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the clinical efficacy of tolvaptan in patients with congestive heart failure (CHF) and chronic kidney disease (CKD) in comparison with furosemide as an active control. In an acute-phase trial, we investigate the impact of CKD on the clinical effectiveness of tolvaptan therapy for CHF with CKD. In the long-term follow up, we investigate whether tolvaptan decelerates the progress of CKD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

1.acute-phase trial
Absolute change of body weight, rate of increase/decrease of body weight.
Development of acute kidney injury on CKD
Bioelectrical impedance analysis: Extracellular water, intracellular water, and total body water

2.long term follow up study
Delta estimated glomerular filtration rate (eGFR), 50% decrease in eGFR
Composite outcome: 50% decrease in eGFR+induction of renal replacement therapy

Key secondary outcomes

1.acute-phase trial
Renal function tests:serum creatinine, eGFR, urine osmolality, and urine 24-hour Na excretion
Neurohumoral factors:plasma renin activity, serum aldosterone, and plasma catecholamine fraction, plasma midkine level, urine angiotensinogen level, urine midkine level, N-terminal prohormone of brain natriuretic peptide, arginine vasopressin, and urine aquaporin-2
Dose of diuretics converted for furosemide
Other concomitant drugs for treating CHF: atrial natriuretic peptides, phosphodiesterase III inhibitors, catecholamines, and colforsins
Health related QOL indicators (SF-36)
Induction of renal replacement therapy
Length of initial hospitalization

2.long-term follow-up study
Absolute change in body weight and rate of change
Health-related QOL indicator measured by using the SF-36
Cardiac echocardiography imaging
Re-hospitalization for CHF
Direct cost of medical expenditure from claim data
Cardiovascular events
Total mortality


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1. acute-phase trial
Start treatment with 15 mg tolvaptan with concomitant use of diuretics prescribed for the initial assessment period of 15 days.

2. long-term follow-up study
Patients who tolerate tolvaptan will continue the treatment for the next 2 years.

Interventions/Control_2

1. acute-phase trial
Start treatment with 40 mg furosemide with concomitant use of diuretics prescribed for the initial assessment period of 15 days.

2. long term follow up study
Patients who tolerate furosemide will continue the treatment for the next 2 years.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Irrespective of the route of administration, the patients are prescribed diuretics equivalent to a dose of furosemide between 20-240 mg/day, and the diuretic dose was not changed between day 1 and day 2
2. Patients satisfying the criteria of GFR <60 ml/min/1.73m2 or urine protein of >=0.50 g/gCr (g/day) or urine protein >=2+ assessed by using test tape
3. Patients satisfying the Framingham criteria for CHF

Key exclusion criteria

1. Patients who recently started undergoing hemodialysis
2. Patients treated with the following drugs during the initial eligibility assessment period
(a) Phosphodiesterase III inhibitors (amrinone, milinone, or loprinone)
(b) Catecholamines
(c) Colforsins
3. Acute renal failure
4. Hypernatremia, Na levels &#8805;147 mEq/dL
5. Patients unable to sense thirst or those with difficulty drinking water
6. Anuria
7. Patients with malignancy, including multiple myeloma or primary amyloidosis
8. Patients suspected of having loss of circulating plasma volume or patients with hypotension
9. Severe aortic stenosis or severe dilated cardiomyopathy
10. Acute coronary syndrome
11. Recent myocardial infarction, percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) within the past 3 months
12. Patients scheduled for PCI or CABG
13. Stroke within the past 3 months
14. Severe neuropsychological deficit
15. Severe liver damage or hepatic coma
16. Severe obstructive and/or restrictive lung disease
17. Severe pulmonary hypertension
18. Patients with other life-threatening illnesses
19. Pregnant women
20. Allergy to tolvaptan
21. Others deemed ineligible for this trial by physicians

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Yuzawa

Organization

Fujita Health University School of Medicine

Division name

Department of Nephrology

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan

TEL

0562-93-9345

Email

hhayashi@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Hayashi

Organization

Fujita Health University School of Medicine

Division name

Department of Nephrology

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref., Japan

TEL

0562-93-9345

Homepage URL


Email

hhayashi@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation, Aichi

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Chita City Hospital, Okazaki City Hospital, TOYOTA Memorial Hospital, Tono Kosei Hospital

Name of secondary funder(s)

Fujita Health University Clinical Research Grant


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



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 09 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

Enrolling by invitation

Date of protocol fixation

2013 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 09 Day

Last modified on

2014 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014031


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name