UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029787 |
|---|---|
| Receipt number | R000033844 |
| Scientific Title | Efficacy and safety of tolvaptan on patients with severe chronic kidney disease complicated by congestive heart failure |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2023/06/08 14:21:43 |
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Basic information
Public title
Efficacy and safety of tolvaptan on patients with severe chronic kidney disease complicated by congestive heart failure
Acronym
Tolvaptan in CKD Stage 4-5 with CHF
Scientific Title
Efficacy and safety of tolvaptan on patients with severe chronic kidney disease complicated by congestive heart failure
Scientific Title:Acronym
Tolvaptan in CKD Stage 4-5 with CHF
Region
| Japan |
Condition
Condition
severe chronic kidney disease complicated by congestive heart failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether tolvaptan affects maintenance of residual renal function in CKD Stage 4-5 patients with congestive heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate to eGFR <6 (mL / min / 1.73 m2)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tolvaptan
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A patient who has an insufficient fluid retention symptom with an existing diuretic (eg furosemide).
2) CKD stage 4-5
Key exclusion criteria
1) Hemodynamics are unstable
2) Hypersensitivity to tolvaptan
3) Anuria
4) Can not feel dry mouth or can not drink water
5) Hypernatremia
6) Pregnant
7) Already prescribed tolvaptan
8) Patient judged inappropriate by the examining physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-sakai@nms.ac.jp
Sponsor or person
Institute
Department of Nephrology, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medicaln School Hospital Ethics Committee
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033844
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
