UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019799
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kinuta@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022872

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.