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
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
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
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
