UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022422 |
|---|---|
| Receipt number | R000025843 |
| Scientific Title | The efficacy of tolvaptan, a vasopressin V2 receptor antagonist, in patients with congestive heart failure and kidney diseases |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/05/15 13:45:00 |
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Basic information
Public title
The efficacy of tolvaptan, a vasopressin V2 receptor antagonist, in patients with congestive heart failure and kidney diseases
Acronym
The efficacy of tolvaptan in patients with congestive heart failure and kidney diseases
Scientific Title
The efficacy of tolvaptan, a vasopressin V2 receptor antagonist, in patients with congestive heart failure and kidney diseases
Scientific Title:Acronym
The efficacy of tolvaptan in patients with congestive heart failure and kidney diseases
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD), Nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To investigate the efficacy of tolvaptan
(2) To clarify effective indices of tolvaptan, in patients with congestive heart failure and kidney diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1. Efficacy of tolvaptan (changes in urine volume, body weight and inferior vena cava diameter)
2. Indices of efficacy of tolvaptan (urine osmotic pressure, urinary aquaporin 2/ plasma vasopressin ratio
Key secondary outcomes
1. Renal function after administration of tolvaptan
2. Side effects of tolvaptan
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. To add tolvaptan 15mg/day to the conventional therapy
2. Not to change other treatments after the start of tolvaptan for one week
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with kidney diseases treated with sodium-excreting diuretics
2. Patients satisfying the Framingham criteria for congestive heart failure
3. Patients who have ability to provide written informed consent
Key exclusion criteria
1. Patients under 20 years of age at time of enrolling
2. Serum Na >=145 mEq/L
3. Patients with difficulty in water intake
4. Anuria
5. Patients with severe liver failure or severe congestive heart failure
6. Others deemed ineligible for this trial by physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Koike |
Organization
Toyama University Hospital
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7297
tkoike@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Koike |
Organization
Toyama University Hospital
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7297
Homepage URL
tkoike@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Toyama Hospital
Saiseikai Takaoka Hospital
Toyama Rosai Hospital
Kamiichi General Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama, Japan
Tel
076-434-7681
rinri@adm.u-toyama.ac.jp
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
富山大学附属病院（富山県）
（Toyama University Hospital (Toyama) ）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10157-023-02325-1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-023-02325-1
Number of participants that the trial has enrolled
30
Results
As compared to baseline, urine volume increased at day 7 in 17 responders, whereas urine volume decreased at day 7 in 13 non-responders. Baseline urine cyclic AMP/plasma AVP ratio distributed between 0.25 and 4.01 with median 1.90. The urine cyclic AMP/plasma AVP ratio was a significant predictor of response to tolvaptan, which was adjusted for 6 potential confounders with a cutoff of 1.24.
Results date posted
| 2023 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 08 | Day |
Baseline Characteristics
(Inclusion criteria)
1. Patients above 20 years of age at time of enrolling
2. Patients with kidney diseases treated with sodium-excreting diuretics
3. Patients satisfying the Framingham criteria for congestive heart failure
4. Patients who have ability to provide written informed consent
(Exclusion criteria)
1. Patients under 20 years of age at time of enrolling
2. Serum sodium above 145 mEq/L
3. Patients with difficulty in water intake
4. Anuria
5. Patients with severe liver failure or severe congestive heart failure
6. Others deemed ineligible for this trial by physicians
Participant flow
All included patients were followed following the initiation of tolvaptan for seven days. The day before the initiation of tolvaptan was defned as day 0. Trends in urine volume and body weight during 7-day tolvaptan therapy were monitored. The primary endpoint was any increases in urine volume at day 7 from day 0. A responder has an increased urine volume on day 7 from day 0. A non-responder has a decrease in urine volume on day 7 as compared to day 0. An independent variable was defined as the baseline urine cyclic AMP/plasma AVP ratio, which was measured at day 0 prior to the initiation of tolvaptan. The prognostic impact of this independent variable upon the primary endpoint was investigated.
Adverse events
None of the subjects experienced side effects.
Outcome measures
the usefulness of urine cyclic AMP/plasma AVP ratio for prediction of response to tolvaptan
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025843
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