UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008712 |
|---|---|
| Receipt number | R000010233 |
| Scientific Title | Efficasy and safety of tolvaptan in patients undergoing peritoneal dialysis with heart failure despite the standard treatment with conventional |
| Date of disclosure of the study information | 2012/08/17 |
| Last modified on | 2013/02/18 08:55:09 |
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Basic information
Public title
Efficasy and safety of tolvaptan in patients undergoing peritoneal dialysis with heart failure despite the standard treatment with conventional
Acronym
Effects of tolvaptan in patients undergoing pertoneal dialysis with heart failure
Scientific Title
Efficasy and safety of tolvaptan in patients undergoing peritoneal dialysis with heart failure despite the standard treatment with conventional
Scientific Title:Acronym
Effects of tolvaptan in patients undergoing pertoneal dialysis with heart failure
Region
| Japan |
Condition
Condition
Chronic Heart Failure, Chronic Renal Failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing investigation of efficacy and safety between the standard treatment group of administration of furosemide and tolvaptan combination group in patients undergoing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Body Weight
Key secondary outcomes
urine volume, urine osmolarity, serum osmolarity, serum electrolyte concentration, hANP, BNP, fluid retention, water intake, NYHA functional classification, serum ADH, creatinine clearance, urine electrolyte concentration, total removed fluid with PD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptane combination group: furosemide at a dose of 120mg daily for 3 days given in combination with
tolvaptan 15mg/day
Interventions/Control_2
Conventional treatment group: furosemide at a dose of 120mg daily for 3 days
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)The patients with chronic heart failure
2)The patients undergoing peritoneal dialysis
3)The admitted patients
4)Male and Female
5)The patients over 20 years old in a time of consent
6)The patients with individual or representitive consent
Key exclusion criteria
1)The patients showing allergy to tolvaptan or similar compound (ex. mozavaptan)
2)The patients showing allergy to sulfonamide
3)The anuric patients
4)The patients without a sense of thirst or ability to intake water
5)The patients with hypernatremia
6)The pregnant patients
7)The patients taking tolvaptan at the time of enrolling
8)The patitents in need of emergency medical care for massive heart failure
9)The patients given furosemide over 120mg/day at the time of enrolling
10)The patients with hepatic coma
11)The patients regarded as inappropriate for this clinical study by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hayakawa M.D., Ph.D. |
Organization
The Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hayakawa M.D., Ph.D. |
Organization
The Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Division of Kidney and Hypertension, the Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Kidney and Hypertension, the Jikei University School of Medicine
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
Address
Tel
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
| 2012 | Year | 08 | Month | 17 | 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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | 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
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010233
| 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 |
