UMIN-CTR Clinical Trial

Public title

Acid-base status and chronic kidney disease-mineral and bone disorder in hemodialysis patients: Results from the nationwide registry of the Japanese Society for Dialysis Therapy

Acronym

Acid-base status and chronic kidney disease-mineral and bone disorder

Scientific Title

Acid-base status and chronic kidney disease-mineral and bone disorder in hemodialysis patients: Results from the nationwide registry of the Japanese Society for Dialysis Therapy

Scientific Title:Acronym

Acid-base status and chronic kidney disease-mineral and bone disorder

Region

Japan

Condition

Chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Metabolic acidosis in hemodialysis patients is one of important factors for chronic kidney disease-mineral and bone disorder (CKD-MBD). Little attention has been given to the influence of acid-base status on CKD-MBD. In worldwide guidelines (DOPPS in 2004, EBPG in 2007, and UKRAG in 2009), pre-dialysis bicarbonate level for hemodialysis patients was recommended to maintain 18-24 mEq/L from a prognostic viewpoint, while K/DOQI guidelines in 2003 yielded conflicting results (more than 22 mEq/L) from a viewpoint of bone metabolism and disease. The discrepancy is due to the fact that post-dialysis overalkalization develops in such situation of more than 22 mEq/L of pre-dialysis bicarbonate level, and leads to precipitate metastatic calcification and cardiovascular death.
The goal of this study is to clarify the optimal correction of metabolic acidosis for preventing cardiovascular event and death.

Basic objectives2

Others

Basic objectives -Others

Cross-sectional study is made of hemodialysis patients who received hemodialysis at least 1 year and 3 times a week. Data are obtained from the nationwide registry of the Japanese Society for Dialysis Therapy (2008-2009), including 52,432 HD patients. The relationship between pre-dialysis acid-base status (bicarbonate and pH level) and patient information (patients background, dialysis dose, nutritional factor, clinical data and using dialysate) is analyzed, and cardiovascular mortality and event of myocardial infarction are followed during 1 year.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Myocardial infarction
Death

Key secondary outcomes

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

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Hemodialysis patients who received hemodialysis at least 1 year and 3 times a week.

Key exclusion criteria

None.

Target sample size

52432

Name of lead principal investigator

1st name
Middle name
Last name	Tadashi Yamamoto

Organization

Shirasagi Hospital

Division name

Research Division

Zip code

Address

7-11-23 Kumata, Higashisumiyoshi, Osaka 546-0002, Japan

TEL

06-6714-1661

Email

Name of contact person

1st name
Middle name
Last name	Tadashi Yamamoto

Organization

Shirasagi Hospital

Division name

Research Division

Zip code

Address

7-11-23 Kumata, Higashisumiyoshi, Osaka 546-0002, Japan

TEL

06-6714-1661

Homepage URL

http://www.shirasagi-hp.or.jp/

Email

yamamoto@shirasagi-hp.or.jp

Institute

Shirasagi Hospital

Institute

Department

Personal name

Organization

Shirasagi Hospital

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

YES

Study ID_1

JRDR10001

Org. issuing International ID_1

Japanese Society for Dialysis Therapy

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

白鷺病院（大阪府）

Date of disclosure of the study information

2012

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://dx.doi.org/10.1053/j.ajkd.2015.04.014

Number of participants that the trial has enrolled

Results

Of 15,132 patients, during follow-up, 1,042 died of all causes, including 408 CV deaths. In the adjusted analysis for all-cause mortality, HRs compared to the reference group were significantly higher in patients with predialysis pH>7.40 (HR, 1.36; 95% CI, 1.13-1.65) and postdialysis pH<7.40 (HR, 1.22;95% CI, 1.00-1.49). Predialysis pH>7.40 was also associated with higher risk of CV mortality (HR, 1.34;95% CI, 1.01-1.79). No association of pre- or postdialysis bicarbonate level with all-cause and CV mortality was observed. Predialysis pH may be the most appropriate reference for accurate correction of metabolic acidosis in dialysis patients.

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

Completed

Date of protocol fixation

2012

Year

04

Month

03

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

08

Day

Last follow-up date

2013

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Cross-sectional observational study from the database of the nationwide registry of the Japanese Society for Dialysis Therapy in 2008-2009.

Registered date

2012

Year

11

Month

08

Day

Last modified on

2017

Year

05

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010906