UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037550 |
|---|---|
| Receipt number | R000042314 |
| Scientific Title | The effect of trichloromethiazide in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2021/02/01 09:32:09 |
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Basic information
Public title
The effect of trichloromethiazide in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
Acronym
The effect of trichloromethiazide in autosomal dominant polycystic kidney disease patients using tolvaptan
Scientific Title
The effect of trichloromethiazide in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
Scientific Title:Acronym
The effect of trichloromethiazide in autosomal dominant polycystic kidney disease patients using tolvaptan
Region
| Japan |
Condition
Condition
Autosomal dominant polycystic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the effect of trichloromethiazide to reduce urine volume by increasing urinary osmolality in ADPKD patients using tolvaptan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Urine volume with urinary osmolality
Key secondary outcomes
Renal function, HRQOL, serum/urinary electrolyte, biomarker, blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antihypertensive treatment including trichloromethiazide
Interventions/Control_2
Standard antihypertensive treatment (without the use of trichloromethiazide)
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
Hypertensive ADPKD patients using tolvaptan
Key exclusion criteria
Exclusion criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); Hyponatremia (serum Na < 135 mEq/L) and/or hypokalemia (serum K < 3.5 mEq/L); prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Ishibashi |
Organization
Japanese Red Cross Medical Center
Division name
Division of Nephrology
Zip code
150-8935
Address
4-1-22 Hiroo,shibuya-ku,Tokyo, Japan
TEL
03-3400-1311
yi431204@gmail.com
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Uchiyama |
Organization
Keio University School of Medicine
Division name
Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3796
Homepage URL
kiyo.0817.piyo@keio.jp
Sponsor or person
Institute
Division of Nephrology, Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical research ethics committee
Address
4-1-22 Hiroo,shibuya-ku,Tokyo, Japan
Tel
03-3400-1311
rinri@med.jrc.or.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
| 2019 | Year | 07 | 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
10
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042314
