UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001188
Receipt number 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 19:59:26

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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 or person

Institute

Osaka General Medical Center

Institute

Department

Personal name



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

Value
https://center6.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