UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Serum Cystatin C Is a Significant Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Title of the study (Brief title)	Diagnostic Marker of the Renal Resistive Index Detected on Doppler Ultrasound in Patients with Chronic Kidney Disease
Region	Japan

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

Objectives
Narrative objectives1	To elucidate whether the serum Cystatin C level is associated with signs of vascular dysfunction such as arterial stiffness, a major determinant of prognosis, in human subjects with chronic kidney disease (CKD).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between serum Cystain C and Renal Resistive Index
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inpatients
Key exclusion criteria	none
Target sample size	100

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

Public contact
Name of contact person	Ayu Akiyama
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	ayu8823@mx31.tiki.ne.jp

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

Funding Source
Organization	None
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 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 25 Day
Anticipated trial start date	2011 Year 04 Month 01 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	Published
URL releasing results
Results
Other related information	We determined the levels of serum CysC in 83 CKD patients (median age: 57.0 years, male: 67.5%, diabetes: 9.6%). The serum CysC level was significantly correlated with the renal RI(P < 0.0001) and baPWV(P = 0.0001). The serum CysC level was a significant determinant of the renal RI(P = 0.0006) in a multivariate regression analysis using a biomarker model. The multivariate odds ratio of the serum CysC level for a renal RI of 0.70, a level that predicts worse renal outcomes, was significant (4.00, p = 0.0007). The area under the receiver-operating characteristic curve comparing the sensitivity and specificity of CysC for predicting the RI 0.70 was 0.925 (P < 0.0001) (cutoff value: 2.04 mg/L).

Management information
Registered date	2014 Year 06 Month 20 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016681