UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019799 |
|---|---|
| Receipt number | R000022872 |
| Scientific Title | Studies on relationship between estimating glomerular filtration rate (eGFR) and inulin clearance (mGFR) in patients with autosomal dominant polycystic kidney |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2019/05/20 09:50:01 |
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Basic information
Public title
Studies on relationship between estimating glomerular filtration rate (eGFR) and inulin clearance (mGFR) in patients with autosomal dominant polycystic kidney
Acronym
Studies on relationship between estimating glomerular filtration rate (eGFR) and inulin clearance (mGFR) in patients with autosomal dominant polycystic kidney
Scientific Title
Studies on relationship between estimating glomerular filtration rate (eGFR) and inulin clearance (mGFR) in patients with autosomal dominant polycystic kidney
Scientific Title:Acronym
Studies on relationship between estimating glomerular filtration rate (eGFR) and inulin clearance (mGFR) in patients with autosomal dominant polycystic kidney
Region
| Japan |
Condition
Condition
autosomal dominant polycystic kidney disease
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between measured GFR (inulin clearance) and estimating GFR (eGFR) in patients with autosomal dominant polycystic kidney disease (ADPKD).
Basic objectives2
Others
Basic objectives -Others
Examination of one year later, mGFR and eGFR.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare between mGFR and eGFR of the same period
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ADPKD
Key exclusion criteria
Patients with ESRD
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kikuo |
| Middle name | |
| Last name | Nutahara |
Organization
Kyorin University School of Medicine
Division name
Department of Urology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi
TEL
0422-47-5511
kinuta@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Kikuo |
| Middle name | |
| Last name | Nutahara |
Organization
Kyorin University School of Medicine
Division name
Department of Urology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi
TEL
0422-47-5511
Homepage URL
kinuta@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
Kyorin University
Address
6-20-2, Shinkawa, Mitaka-shi
Tel
0422-47-5511
kinuta@ks.kyorin-u.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
杏林大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | 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 | 04 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 01 | Day |
Other
Other related information
Case control study.
We intended for ADPKD patients who did not reach the renal insufficiency that we received after April, 2012.
We measure inulin clearance and serum creatinine in all patients.
Compare the relationship between mGFR and eGFR in each patient.
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022872
| Research Plan | |
|---|---|
| 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 |
