UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013880 |
|---|---|
| Receipt number | R000016194 |
| Scientific Title | A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2022/05/09 14:15:24 |
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Basic information
Public title
A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease
Acronym
PKD cohort study
Scientific Title
A prospective cohort study for evaluating rissk of renal function and survival in patients with polycystic kidney and liver disease
Scientific Title:Acronym
PKD cohort study
Region
| Japan |
Condition
Condition
polycystic kidney disease, polycystic liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine risks of end stage renal disease and survival in patients with polycystic kidney and liver diseases, with analyzing epidemiology of the disease in Japan.
Basic objectives2
Others
Basic objectives -Others
To evaluate cystic growth; and incidence of cerebrovascular disease, heart disease, and respiratory disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal failure and survival
Key secondary outcomes
Change of cystic volume. Incidence of cerebrovascular disease, heart disease, and respiratory disease.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with polycystic kidney disease and/or polycystic liver disease.
Key exclusion criteria
Patients who are not willing to enroll the study, and those who are considered not eligible to this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Ubara |
Organization
Toranomon Hospital Kajigaya
Division name
Nephrology Center
Zip code
2138587
Address
1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-877-5111
ubara@toranomon.gr.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
akinari-s@toranomon.gr.jp
Sponsor or person
Institute
Nephrology Center, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
IRB, Toranomon Hospital
Address
2-2-2, Toranomon, Minato-ku
Tel
0335881111
chiken-jim@toranomon.gr.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
虎の門病院（東京都）、虎の門病院分院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 30 | 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
| 2014 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood and urine samples, and related examinations will be performed as daily practice. A part of samples would be stored for further evaluation of outcomes.
Management information
Registered date
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016194
