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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014093
Receipt No. R000016396
Official scientific title of the study Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Date of disclosure of the study information 2014/05/28
Last modified on 2015/04/16

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Basic information
Official scientific title of the study Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Title of the study (Brief title) Study for new biomarker development in the prediction of prognosis of renal function in chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated the relationship between urinary 5-methyl-2'-deoxycytidine and the prognosis of renal function in chronic kidney disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the doubling of the serum creatinine, the initiation of dialysis therapy
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients and inpatients
Key exclusion criteria dialysis patients
Target sample size 512

Research contact person
Name of lead principal investigator Hitoshi Sugiyama
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Chronic Kidney Disease and Peritoneal Dialysis
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Email pich5fq7@s.okayama-u.ac.jp

Public contact
Name of contact person Akifumi Onishi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Homepage URL
Email pich5fq7@s.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2014 Year 05 Month 28 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 01 Day
Anticipated trial start date
2009 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We determined the urinary 5MedCyd (u5MedCyd) levels using ELISA in human spot urine samples and performed a prospective cohort study. The association between the level of u5MedCyd, levels of estimated GFR (eGFR), albuminuria, alpha 1-microglobulin, and 8-OHdG and renal prognosis were analyzed in 512 CKD patients (mean age: 52.4 years, 54% male, 50% with chronic glomerulonephritis).

Management information
Registered date
2014 Year 05 Month 28 Day
Last modified on
2015 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016396


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