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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037550
Receipt No. 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 2020/08/03

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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
Email 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
Email kiyo.0817.piyo@keio.jp

Sponsor
Institute Division of Nephrology, Japanese Red Cross Medical Center
Institute
Department

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
Email 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 31 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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