UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039725 |
|---|---|
| Receipt number | 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 | 2025/03/10 10:28:44 |
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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
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
akinari-s@toranomon.gr.jp
Sponsor or person
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
Personal name
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
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
188
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under review of the paper.
Date of the first journal publication of results
Baseline Characteristics
This was a Japanese nation-wide, multicenter, retrospective observational study. Between May 2014 and September 2019, 157 patients with ADPKD who developed CKD G5 were included (data: previous 10 years). Patient groups: Tolvaptan (pre-CKD G5), Non-Tolvaptan (pre-CKD G5), Tolvaptan Continuation in CKD G5, Tolvaptan Discontinuation in CKD G5, and Non-Tolvaptan (all phase) groups.
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045248
