UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009228 |
|---|---|
| Receipt number | R000010597 |
| Scientific Title | A study to evaluate the efficacy and safety of Tolvaptan in heart failure patients with peritoneal dialysis |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2012/10/31 10:50:52 |
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Basic information
Public title
A study to evaluate the efficacy and safety of Tolvaptan in heart failure patients with peritoneal dialysis
Acronym
A study to evaluate the efficacy and safety of Tolvaptan in heart failure patients with peritoneal dialysis
Scientific Title
A study to evaluate the efficacy and safety of Tolvaptan in heart failure patients with peritoneal dialysis
Scientific Title:Acronym
A study to evaluate the efficacy and safety of Tolvaptan in heart failure patients with peritoneal dialysis
Region
| Japan |
Condition
Condition
End stage renal disease , heart failure
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the diuretic effect of tolvaptan with existing diuretics in congestive heart failure patients with peritoneal dialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
change of urine volume
Key secondary outcomes
1)change of body weight
2)change of serum electrolyte
3)sCre,eGFR
4) peritoneal function
5)ANP/BNP
6) urine electrolyte
7) serum osmolarity, urine osmolarity
8)Kt/V
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
tolvaptan 7.5mg/day (can be escalated to 15mg, if needed)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients with congestive heart failure
2. patients who already have existing diuretics
3. patients with peritoneal dialysis
4. inpatients
Key exclusion criteria
1.patients who have a history of allergy against tolvaptan or similar compounds
2.anuric patients (urinary output: <100mL/day)
3.patients who cannnot feel thirsty or have difficulty to drink
4.patients whose serum sodium level is over 147mEq/L
5.pregnant or possibly pregnant woman
6. patients who already have taken tolvaptan at randomization
7.patients regarded as inappropriate for this clinical study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Tokita |
Organization
Fujisawa City Hospital
Division name
Department of Nephrology
Zip code
Address
2-6-1Fujisawa, Fujisawa city, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fujisawa City Hospital
Division name
Department of Nephrology
Zip code
Address
2-6-1Fujisawa, Fujisawa city, Kanagawa
TEL
Homepage URL
Sponsor or person
Institute
Fujisawa City Hospital
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
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 | 10 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 31 | Day |
Last modified on
| 2012 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010597
