UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037987 |
|---|---|
| Receipt number | R000043298 |
| Scientific Title | The examination of PKD1/PKD2 gene mutation in patients with autosomal dominant polycystic kidney disease |
| Date of disclosure of the study information | 2019/09/12 |
| Last modified on | 2023/09/24 07:12:38 |
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Basic information
Public title
The examination of PKD1/PKD2 gene mutation in patients with autosomal dominant polycystic kidney disease
Acronym
The examination of PKD1/PKD2 gene mutation in patients with autosomal dominant polycystic kidney disease
Scientific Title
The examination of PKD1/PKD2 gene mutation in patients with autosomal dominant polycystic kidney disease
Scientific Title:Acronym
The examination of PKD1/PKD2 gene mutation in patients with autosomal dominant polycystic kidney disease
Region
| Japan |
Condition
Condition
Autosomal dominant polycystic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In the patients who diagnosed ADPKD, we examine the association between clinical examination and PKD1/PKD2 mutation in the gene of ADPKD.
We determine the risk of renal dysfunction and the complications of patients with ADPKD, and early detection may be possible.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PKD1/PKD2 gene in all exon and exon-intron adjacent regions by sanger method and the next generation sequencer.
Key secondary outcomes
(1) Total kidney volume
(2) Other organs complications (multiple liver cysts, cerebral aneurysm, cardiac valve disease)
(3) Factors of arteriosclerosis (plasma AVP, AGE, ADMA, plasma osmolality, intact-PTH etc)
(4) Factor of the renal function
(5) Factor of the liver function
(6) Factor of diabetes
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had diagnosed with ADPKD from clinical examination.
Key exclusion criteria
The patients who are judged to be inadequate by study doctors.
The patients who are not obtained the agreement.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Moriyama |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
830-0011
Address
67, Asahi-machi, Kurume city, Fukuoka 830-0011, Japan
TEL
0942-31-7002
moriyama_tomofumi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Fukami |
Organization
Kurume University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
830-0011
Address
67, Asahi-machi, Kurume city, Fukuoka 830-0011, Japan
TEL
0942-31-7002
Homepage URL
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
self fumding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Technology Development, Kazusa DNA Research Institute, Chiba, Japan.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University
Address
67, Asahi-machi, Kurume city, Fukuoka 830-0011, Japan
Tel
0942-35-3311
https://www.kurume-u.ac.jp/site/aro/
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
| 2019 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33141305/
Number of participants that the trial has enrolled
58
Results
Tolvaptan (TV) treatment significantly improved %TKV regardless of the type of gene mutation. The results suggest that PKD1-truncating mutations are associated with a higher incidence of cerebral aneurysms.
The PROPKD score was significant negative correlation with %eGFR after TV treatment. Multiple regression analysis also showed that the PROPKD score was a significant contributor to %eGFR after TV initiation.
Results date posted
| 2023 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 25 | Day |
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
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043298
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