UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007247 |
|---|---|
| Receipt number | R000008544 |
| Scientific Title | QOL Evaluation of patients with ADPKD : Comparison with other renal diseases |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2013/05/31 10:54:42 |
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Basic information
Public title
QOL Evaluation of patients with ADPKD : Comparison with other renal diseases
Acronym
QOL Evaluation of ADPKD
Scientific Title
QOL Evaluation of patients with ADPKD : Comparison with other renal diseases
Scientific Title:Acronym
QOL Evaluation of ADPKD
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Renal glomerular diseases ( excluding secondary glomerular disease except nephrosclerosis)
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with ADPKD suffer from unpleasant symptoms related to enlarged kidney and liver, heredity and high risk of intracranial vascular disorders in addition to progressive renal disease. QOL score is compared with patients of other renal diseases.
Basic objectives2
Others
Basic objectives -Others
The relationship between kidney and liver volume and QOL score is evaluated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of QOL score between patients with ADPKD and other renal diseases.
Key secondary outcomes
Relation of QOL score with total kidney and liver volume is evaluated in patients with ADPKD. Kidney and liver volume is measured by MRI.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ADPKD.
Renal glomerular diseases ( exclude secondary renal disease except nephrosclerosis).
Patients who consent to the study.
Key exclusion criteria
Patients who can not answer the questionnaire.
Patients on dialysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University School of Medicine
Division name
Urology, Nephrology & Radiology
Zip code
Address
6-20-2 Shinkawa, Mitaka
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University School of Medicine
Division name
Urology
Zip code
Address
6-20-2 Shinkawa, Mitaka
TEL
0422-47-5511
Homepage URL
ehigashi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
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
Address
Tel
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
杏林大学病院（東京都三鷹市）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Questionnaire (SF-36 and original form designed for symptoms of ADPKD) is answered.
Other relevant clinical data are available from ordinary out-patient records.
Management information
Registered date
| 2012 | Year | 02 | Month | 08 | Day |
Last modified on
| 2013 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008544
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
