UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019176
Receipt number R000022171
Scientific Title A prospective Study examining The contribution to Renal anemia treatment of ferric citrate hydrate, an Ironbased Oral phosphate binder, in hemodialysis patients with hyperphosphatemia : ASTRIO Study
Date of disclosure of the study information 2015/10/01
Last modified on 2017/06/06 13:43:52

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Basic information

Public title

A prospective Study examining The contribution to Renal anemia treatment of ferric citrate hydrate, an Ironbased Oral phosphate binder, in hemodialysis patients with hyperphosphatemia : ASTRIO Study

Acronym

ASTRIO Study

Scientific Title

A prospective Study examining The contribution to Renal anemia treatment of ferric citrate hydrate, an Ironbased Oral phosphate binder, in hemodialysis patients with hyperphosphatemia : ASTRIO Study

Scientific Title:Acronym

ASTRIO Study

Region

Japan


Condition

Condition

Maintenance hemodialysis patients with hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of ferric citrate hydrate administrated for hyperphosphatemia on renal anemia treatment in maintenance hemodialysis patents undergoing ESA therapy by comparing with non-iron based phosphate binders.

Basic objectives2

Others

Basic objectives -Others

Secondary effect on treatment of renal anemia

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in ESA dose from baseline to the end of treatment.

Key secondary outcomes

1) Cumulative dose of intravenous iron during the study.
2) Cumulative dose of ESA during the study.
3) ESA dose at each observation.
4) ERI at each observation.
5) Red blood cell related parameters at each observation.
6) Iron related parameters at each observation.
7) CKD-MBD related parameters at each observation.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients will be treated for 24 weeks with ferric citrate hydrate switched from phosphate binder that has been used before entry.

Interventions/Control_2

Patients will be treated for 24weeks with previous phosphate binder used before entry.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients receiving hemodialysis
2) Patients receiving non-iron based phosphate binders.
3) Patients receiving a constant dose of ESA
4) Patients who provided voluntary informed consent to participate in the study

Key exclusion criteria

1) Patients who have administrated of oral iron agents within 4weeks before entry.
2) Patients with uncontrolled serum P
3) Patients with uncontrolled serum Ca
4) Patients with uncontrolled serum Hb
5) Patients with uncontrolled hypertension

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keitaro Yokoyama

Organization

The Jikei University School of Medicine

Division name

Division of Nephrology and Hypertension, Department of Internal Medicine

Zip code


Address

3-25-8, Nishi-Shinbashi,Minato-ku,Tokyo

TEL

03-3433-1111

Email

keitaro@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kotaro Senuki

Organization

Sogo Rinsho Medefi Co., Ltd

Division name

Project promotion department

Zip code


Address

KDX Shinjuku Bldg. 9F 3-2-7 Nishi-Shinjuku, Shinjuku-ku, Tokyo

TEL

03-6901-6079

Homepage URL


Email

RIO-J01@sogo-medefi.jp


Sponsor or person

Institute

Japan Tobacco Inc.

Institute

Department

Personal name



Funding Source

Organization

Japan Tobacco Inc.
Torii Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2015 Year 10 Month 01 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

2015 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2016 Year 08 Month 08 Day

Date of closure to data entry

2016 Year 10 Month 31 Day

Date trial data considered complete

2016 Year 11 Month 30 Day

Date analysis concluded

2017 Year 01 Month 26 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 30 Day

Last modified on

2017 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022171


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name