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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001188
Receipt No. R000001453
Scientific Title Urinary type IV collagen in chronic kidney disease (CKD): Prospective multi-center observational study.
Date of disclosure of the study information 2008/06/13
Last modified on 2015/07/01

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Basic information
Public title Urinary type IV collagen in chronic kidney disease (CKD): Prospective multi-center observational study.
Acronym Urinary type IV collagen in chronic kidney disease (CKD)
Scientific Title Urinary type IV collagen in chronic kidney disease (CKD): Prospective multi-center observational study.
Scientific Title:Acronym Urinary type IV collagen in chronic kidney disease (CKD)
Region
Japan

Condition
Condition Chronic Kidney Disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study 1) The first aim of this study is to assess the levels of urinary type IV collagen in various renal diseases.
Study 2) The second aim is to predict prognosis of renal disease by its level.
Basic objectives2 Others
Basic objectives -Others To assess the efficacy of urinaty type IV collagen as a diagnostic or predictive marker of CKD.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Study 1) Subtypes of renal disease diagnosed by renal biopsies.
Study 2) Change in e-GFR
Key secondary outcomes 1) Time to a 50% increase of the baseline serum creatinine level at the first renal biopsy.
2) Urinary Protein.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Both inpatients and outpatients with chronic kidney disease (CKD)
Key exclusion criteria Patients with cancer, liver cirrhosis and maintenance dialysis were excluded. Pregnant patients were also excluded.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Furumatsu
Organization Osaka University Graduate School of Medicine
Division name Nephrology
Zip code
Address 2-2, Box (B6), Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3857
Email furumatsu@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Furumatsu
Organization Osaka University Graduate School of Medicine
Division name Nephrology
Zip code
Address 2-2, Box (B6), Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3857
Homepage URL
Email furumatsu@yahoo.co.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20699621
Number of participants that the trial has enrolled
Results
Urinary type IV Collagen (u-IVc) levels were elevated with the increase in u-Protein, HbA1c and Selectivity Index. In addition, among nondiabetic kidney disease, elevation of u-IVc was observed in patients with membranous nephropathy and ANCA, which might reflect the thickening of basement membrane or severe kidney damage.
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 Open public recruiting
Date of protocol fixation
2008 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information In a small sample size cross-sectional observational study, the higher concentration of urinary type IV collagen in membranous nephropathy than other renal diseases was indicated (Makino H et al. Research Communications in Molecular Pathology and Pharmacology 1995). We are going to confirm this fact by a major-scale prospective observational study.

Management information
Registered date
2008 Year 06 Month 13 Day
Last modified on
2015 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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