UMIN-CTR Clinical Trial

Public title

Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease

Acronym

VCOHP Study

Scientific Title

Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease

Scientific Title:Acronym

VCOHP Study

Region

Japan

Condition

Chronic kidney disease

Classification by specialty

Medicine in general	Cardiology	Nephrology
Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the degree of progression of cerebro- and cardio-vascular complication in predialysis, hemodialysis, and peritoneal dialysis patients with chronic kidney disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Alteration of brain volume in MRI
2. Alteration of calcification score in coronary CT

Key secondary outcomes

1. Incidence rate of overt cerebro- and cardio-vascular complications
2. Intima-media thickness of common carotid artery
3. Cardiac function examined by echocardiography and cine-MRI
4. Pulse wave velocity examined by MRI
5. Augmentation Index (AI)
6. Bone mineral density examined by dual-energy X-ray absorptiometry
7. Residual renal function
8. Higher brain function quantified using Japan Stroke Scale Higher Cortical Function (JSS-H)
9. Quality of life quantified using the Kidney Disease Quality of Life Short Form (KDQOL-SF)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Predialysis patients with chronic kidney disease
2. Patients with end-stage renal disease on either hemodialysis or peritoneal dialysis, who started dialysis within 2 years of study entry

Key exclusion criteria

1. Pregnant women, or women who have a possibility of pregnancy
2. Patients using acidic dialysate
3. Patients who have previously received another dialysis therapy for over 3 months
4. Patients who have previously undergone renal transplantation

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiko Tsuruya

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Integrated Therapy for Chronic Kidney Disease

Zip code

Address

Maidashi 3-1-1, Higashi-ku, Fukuoka

TEL

092-642-5843

Email

tsuruya@intmed2.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hisako Yoshida

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Integrated Therapy for Chronic Kidney Disease

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582

TEL

092-642-5843

Homepage URL

Email

hisako@kcu.med.kyushu-u.ac.jp

Institute

Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name

Organization

Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2008

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2008

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Predialysis chronic kidney disease patients and patients with end-stage renal disease on hemodialysis (HD) and peritoneal dialysis (PD) whose dialysis duration is within 2 years are recruited and registered. All patients undergo brain MRI, chest CT, echocardiography, cine-MRI, carotid artery echo, pulse wave velocity examination, and dual-energy X-ray absorptiometry, and are examined higher brain function using Japan Stroke Scale Higher Cortical Function (JSS-H) and quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) at the entry and 2 years later. The changes of these parameters during 2 years are compared among predialysis, HD and PD patients.

Registered date

2008

Year

12

Month

18

Day

Last modified on

2013

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001830