UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013972
Receipt number R000016277
Scientific Title Effect of iron-contained phosphate binder on serum FGF23 in hemodialysis patients.
Date of disclosure of the study information 2014/05/19
Last modified on 2014/08/27 15:55:48

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Basic information

Public title

Effect of iron-contained phosphate binder on serum FGF23 in hemodialysis patients.

Acronym

Effect of iron-contained phosphate binder on serum FGF23 in hemodialysis patients.

Scientific Title

Effect of iron-contained phosphate binder on serum FGF23 in hemodialysis patients.

Scientific Title:Acronym

Effect of iron-contained phosphate binder on serum FGF23 in hemodialysis patients.

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate serum FGF23 concentration when phosphate binder is converted for sevelamer-HCl to Ferric citrate hydtate in hemodialysis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the change of serum FGF23 concentration

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Converting of phosphate binder for sevelamer-HCl to ferric citrate hydrate in hemodialysis patients.

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

hemodialysis patients with sevelamer-HCl

Key exclusion criteria

excess of iron

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiei Narita

Organization

Niigata University Medical and Dental Hospital

Division name

Department of Nephrology

Zip code


Address

1-757 Asahimachi-dori, Niigata, 951-8510 Japan

TEL

025-227-2200

Email

naritai@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Iguchi

Organization

Ojiya general hospital

Division name

internal medicine

Zip code


Address

1-13-33 Honcho, Ojiya city, 947-8601

TEL

0258-83-3600

Homepage URL


Email

igucci4444@yahoo.co.jp


Sponsor or person

Institute

Ojiya general hospital

Institute

Department

Personal name



Funding Source

Organization

Niigata University

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


Address


Tel


Email



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 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 05 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 19 Day

Last follow-up date

2014 Year 08 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 16 Day

Last modified on

2014 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name