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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039725
Receipt No. R000045248
Scientific Title A national survey of ADPKD patients in CKD stage G5
Date of disclosure of the study information 2020/05/01
Last modified on 2021/03/16

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Basic information
Public title A national survey of ADPKD patients in CKD stage G5
Acronym ADPKD G5 Registry
Scientific Title A national survey of ADPKD patients in CKD stage G5
Scientific Title:Acronym ADPKD G5 Registry
Region
Japan

Condition
Condition autosomal dominant polycystic kidney disease(ADPKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We make ADPKD G5 Registry, and clarify the actual situation of ADPKD patients in CKD stage 5.
We investigate the difference the decline of renal dysfunction in CKD stage G5, depending on whether or not the patient has been exposed to Tolvaptan in CKD stage G3-4.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the actual situation of ADPKD patients in CKD stage 5
the decline of renal dysfunction in CKD stage G5
Key secondary outcomes the rate of increase in the TKV

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. age over 20 at May 2014
2. ADPKD patients in CKD stage G5 refferred to the institution which participates in this study, from May 2014 to September 2019
3. The patients who were obtained of the agreement
Key exclusion criteria The patients who are not willing to enroll the study and who are judged inappropriate the study by responsibility doctors.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Muto
Organization Juntendo University, Graduate School of Medicine
Division name Department of Urology
Zip code 1138431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1227
Email s-muto@juntendo.ac.jp

Public contact
Name of contact person
1st name Akinari
Middle name
Last name Sekine
Organization Toranomon Hospital
Division name Nephrology Center
Zip code 1058470
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL 03-3588-1111
Homepage URL
Email akinari-s@toranomon.gr.jp

Sponsor
Institute a Grant-in-Aid for Intractable Renal Diseases Research, Research on rare and intractable diseases, Health and Labour Sciences Research Grants from the Ministry of Health, Labour and Welfare of Japan
Institute
Department

Funding Source
Organization a Grant-in-Aid for Intractable Renal Diseases Research, Research on rare and intractable diseases, Health and Labour Sciences Research Grants from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Juntendo University
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel 03-3814-5672
Email s-muto@juntendo.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
2020 Year 05 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 Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 24 Day
Date of IRB
2019 Year 12 Month 27 Day
Anticipated trial start date
2019 Year 12 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We extract the following observation contents.
(1) Basics information: Sex, age, family history, hepatic cyst, cerebral aneurysm, valvular disease of the heart, diverticula of colon, diabetes, height, weight, blood pressure, dialysis, presence or absence of depression treatment, presence of the anemia, Tolvaptan therapy
(2) Blood test: Hb, Ht, TP, Alb, UN, Cre, eGFR, cystatin C, UA, Na, K, AST, ALT, LDH, ALP, GTP, GA, HbA1c
(3) Urinary test: Hematuria, Proteinuria
(4) Total Kidney Volume(TKV), longer axis of the kidney

Management information
Registered date
2020 Year 03 Month 06 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045248

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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