UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014674 |
|---|---|
| Receipt number | R000017066 |
| Scientific Title | ADPKD cohort study |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2026/02/05 09:38:27 |
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Basic information
Public title
ADPKD cohort study
Acronym
ADPKD cohort study
Scientific Title
ADPKD cohort study
Scientific Title:Acronym
ADPKD cohort study
Region
| Japan |
Condition
Condition
autosomal dominant polycystic kidney disease(ADPKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the increase speed of the kidney capacity of the autosomal dominant polycystic kidney disease (ADPKD) patient and renal function aggravation speed. In addition, We examine the frequency of complications in ADPKD and prevalence in Ibaraki.
Basic objectives2
Others
Basic objectives -Others
1)Epidemiology investigation and complications in ADPKD
2)Influence of quality of life (QOL) and the hypoxemia
3)Effect of tolvaptan
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the increase of kidney volume
Key secondary outcomes
(1) Aggravation speed of renal function (eGFR or the inulin clearance
(2) Death
(the cause of death:) Infectious disease, malignant tumor, cardiovascular disease, cerebropathy, liver failure, respiratory failure, sudden death, other (accident, fall) ignorance)
(3) Kidney composition endpoint (more than 25% drop of dialysis introduction, renal transplantation, 1/sCr or eGFR, renal artery embolus therapy)
(4) Cardiovascular event (cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, myocardial infarction, angina, heart failure, peripheral artery stenosis to need hospitalization)
(5) Infectious disease (cyst infection, large intestine diverticulitis) to need hospitalization
(6) Cyst bleeding to need hospitalization
(7) Serious liver damage
(an ascent more than the twice the standard value upper limit of total bilirubin and a rise more than 3 times of the standard value upper limit in serum ALT or AST)
(8) Kidney plasma flow quantity
(9) Prevalence
(10) Gene variation
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
ADPKD
Key exclusion criteria
The patient who study responsibility doctor or study allotment doctor judged inappropriate patient.
The patient who was not agreed informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
university of tsukuba,faculty of medicine
Division name
department of nephrology
Zip code
305-8575
Address
1-1-1,Tennodai,Tsukuba,Ibaraki, Japan
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hirayasu |
| Middle name | |
| Last name | Kai |
Organization
university of tsukuba,faculty of medicine
Division name
department of nephrology
Zip code
3058575
Address
1-1-1,Tennodai,Tsukuba,Ibaraki, Japan
TEL
029-853-3202
Homepage URL
hirayasu.kai@md.tsukuba.ac.jp
Sponsor or person
Institute
university of tsukuba,faculty of medicine,department of nephrology
Institute
Department
Personal name
Funding Source
Organization
university of tsukuba,faculty of medicine,department of nephrology,Money of authorized accounting
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
Tsukuba Clinical Research & Development Organization
Address
Tsukuba city, Amakubo, 2-1-1
Tel
0298533914
rinshokenkyu@un.tsukuba.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
| 2014 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017066
Publication of results
Published
Result
URL related to results and publications
Kidney Medicine. 2025 Jul 9;7(9):101059. doi: 10.1016/j.xkme.2025.101059.
Number of participants that the trial has enrolled
200
Results
Among 169 patients for whom genetic diagnosis was performed, genetic mutations were identified in 144 cases, with 109 (75.7%) PKD1, 34 (23.6%) PKD2, and one (0.7%) GANAB variant identified. The median annual increase in TKV was 5.9%. Among the patients who were followed, 60 patients (33.5%) achieved the composite renal endpoint. The independent risk factors for reaching the renal composite endpoint were eGFR at enrollment and PKD1 truncation.
Results date posted
| 2026 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 10 | Day |
Baseline Characteristics
Patients with ADPKD
Participant flow
2-year prospective cohort of 200 patients with ADPKD
Adverse events
none
Outcome measures
The primary endpoint was the rate of increase in total kidney volume (TKV). The secondary endpoints were composite renal endpoints (induction of dialysis, renal transplantation, or a decrease in the estimated glomerular filtration rate [eGFR] of 25% more).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
200 patients in ADPKD would be enrolled.
A registration period: From an Ethical Review Board approval day to March 31, 2020.
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017066
