UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022935
Receipt number R000026433
Scientific Title The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/01 20:13:16

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Basic information

Public title

The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.

Acronym

The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.

Scientific Title

The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.

Scientific Title:Acronym

The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.

Region

Japan


Condition

Condition

CKD-MBD in hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To weigh the usage of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The achievement rate of serum phosphate value.

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

All cases investigation

Key exclusion criteria

Nothing

Target sample size

3600


Research contact person

Name of lead principal investigator

1st name Hirokazu
Middle name
Last name Okada

Organization

Saitama Medical University

Division name

Department of Nephrology

Zip code

350-0451

Address

38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan

TEL

049-276-1611

Email

hirookda@saitama-med.ac.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Amano

Organization

Saitama Medical University

Division name

Department of Nephrology

Zip code

350-0451

Address

38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan

TEL

049-276-1611

Homepage URL


Email

hiama@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University

Address

38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan

Tel

049-276-1111

Email

hirb@saitama-med.ac.jp


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

2016 Year 07 Month 01 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/30783915

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/30783915

Number of participants that the trial has enrolled

1373

Results

The median serum phosphorus, corrected calcium and intact PTH for April 2015 were 5.4 mg / dL, 9.1 mg / dL and 147 pg / dL, respectively. In addition,more PB types were significantly correlated with higher serum phosphorus levels (p < 0.001). Compared with other agents, significant change was observed only in FeC group, and serum phosphorus decreased by 0.6 mg / dL (N = 39, p = 0.006). Furthermore, in the same group, hemoglobin increased from 10.4 mg / dL to 11.4 mg / dL (p = 0.002).

Results date posted

2019 Year 07 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Hemodialysis patients in dialysis facilities in western Saitama

Participant flow

Of the 54 facilities, 25 facilities participated. 1641 cases were entered, but 1373 cases were finally entered in the test from exclusion criteria.

Adverse events

non

Outcome measures

We evaluated the basic data of western Saitama dialysis patients and compared the changes in serum phosphorus levels when one new phosphate binder was additionally administered.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 06 Month 06 Day

Date of IRB

2016 Year 06 Month 06 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2017 Year 04 Month 30 Day

Date of closure to data entry

2017 Year 04 Month 30 Day

Date trial data considered complete

2017 Year 04 Month 30 Day

Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2016 Year 06 Month 28 Day

Last modified on

2019 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=R000026433


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name