UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061211 |
|---|---|
| Receipt number | R000070040 |
| Scientific Title | A Multicenter Observational Study on the Long-term Prognosis of Patients with Polycystic Kidney Disease:Japanese National Registry for long-term prognosis of ADPKD (JRP-PROG) |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 11:26:36 |
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Basic information
Public title
A Multicenter Observational Study on the Long-term Prognosis of Patients with Polycystic Kidney Disease
Acronym
A Study on the Long-term Prognosis of Patients with Polycystic Kidney Disease
Scientific Title
A Multicenter Observational Study on the Long-term Prognosis of Patients with Polycystic Kidney Disease:Japanese National Registry for long-term prognosis of ADPKD (JRP-PROG)
Scientific Title:Acronym
A Study on the Long-term Prognosis of Patients with Polycystic Kidney Disease
Region
| Japan |
Condition
Condition
Polycystic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted as part of the Ministry of Health, Labour and Welfare's research program on "Intractable Kidney Diseases" and aims to identify risk factors associated with the long-term prognosis of patients with ADPKD, including renal outcomes, overall survival, ADPKD-related complications, and comorbidities.
Basic objectives2
Others
Basic objectives -Others
To identify factors associated with disease progression through observational research.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of a >=30% decline in eGFR, a >=50% decline in eGFR, or initiation of kidney replacement therapy
Key secondary outcomes
Rate of eGFR decline during the observation period
Rate of increase in total kidney volume (TKV)
Death
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD):
Patients who meet the diagnostic criteria for ADPKD as defined in the Polycystic Kidney Disease (PKD) Clinical Practice Guidelines 2020.
eGFR>=16mL/min/1.73m2
Key exclusion criteria
Patients receiving kidney replacement therapy (hemodialysis, peritoneal dialysis, or post-kidney transplantation)
Patients deemed unsuitable for inclusion in the study by the principal investigator for any other reason
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hoshino |
Organization
Tokyo Women's Medical University
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo Japan
TEL
03-3353-8112
hoshino.junichi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kataoka |
Organization
Tokyo Women's Medical University
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo Japan
TEL
03-3353-8111
Homepage URL
kataoka.hiroshi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Research Study on Intractable Renal Diseases by the Ministry of Health, Labour and Welfare (MHLW)
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
Ethical review board of Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo Japan
Tel
03-3353-8112
rinri.bm@twmu.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
| 2026 | Year | 04 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective multicenter cohort study evaluates associations between baseline clinical characteristics (including age, sex, blood pressure, kidney volume, and comorbidities) and long-term renal outcomes in patients with ADPKD.
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070040
