UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023657
Receipt number R000027243
Scientific Title Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.
Date of disclosure of the study information 2016/08/17
Last modified on 2018/06/19 17:03:29

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Basic information

Public title

Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.

Acronym

Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.

Scientific Title

Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.

Scientific Title:Acronym

Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.

Region

Japan


Condition

Condition

Hyperphosphatemia in chronic kidney disease patients on hemodialysis

Classification by specialty

Endocrinology and Metabolism Nephrology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of switching existing drugs for the treatment of hyperphosphatemia to sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MDB and the improvement of renal anemia in hemodialysis patients with hyperphosphatemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Efficacy endpoints:
1)Serum phosphate concentration (change in serum phosphate concentration, rate and timing of achievement of target serum phosphate concentration) at each evaluation point
2)Laboratory test data related to red blood cells at each evaluation point
3)Corrected serum calcium concentration at each evaluation point
4)Serum intact-PTH concentration at each evaluation point
5)Ca-P product at each evaluation point
6)FGF23 level at each evaluation point
7)Dose of calcium carbonate at each evaluation point
8)Dose of the study drug at each evaluation point
9)Cumulative dose of ESA during the study drug administration period
10)Cumulative dose of intravenous iron during the study drug administration period

Safety endpoints:
1)Adverse events
2)Adverse drug reactions
3)Laboratory test data related to iron at each evaluation point
4)Highly sensitive CRP level at each evaluation point

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switch existing drugs for the treatment of hyperphosphatemia to the administration of sucroferric oxyhydroxide TID for 16 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who have been undergoing hemodialysis (HD or HDF) 3 or more times/week for 12 weeks or longer prior to entry and are scheduled to receive hemodialysis under the same procedures and conditions
2)Patients who have been treated with drugs for hyperphosphatemia other than the study drug at a dose exceeding a specific level for 4 weeks or longer prior to entry
3)Patients with a serum phosphate level of more than 6 mg/dL at the latest examination prior to entry
4)Patients aged 20 years or older at the time of consent
5)Patients who have given written consent

Key exclusion criteria

1)Patients with a serum ferritin level of 300 ng/mL or more at the latest examination prior to entry
2)Patients with a history of hypersensitivity to the ingredients of sucroferric oxyhydroxide (chewable tablet)
3)Patients who are or may be pregnant or are breast-feeding
4)Patients who are considered inappropriate for participation in this study by the investigator's judgment

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiko Miya

Organization

Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group

Division name

Department of Internal Medicine and Dialysis Internal Medicine

Zip code


Address

1-39 Kitasakoichibancho, Tokushima-shi, Tokushima

TEL

088-631-0110

Email

miya@khg.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Miyajima

Organization

Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group

Division name

General Affairs Section

Zip code


Address

1-39 Kitasakoichibancho, Tokushima-shi, Tokushima

TEL

088-631-0110

Homepage URL


Email

a.miyajima@khg.or.jp


Sponsor or person

Institute

Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group

Institute

Department

Personal name



Funding Source

Organization

Kissei Pharmaceutical Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kawashima Dialysis Clinic, Social Medical Corporation Kawashima Hospital Group
Kamoshima Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group
Naruto Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group
Wakimachi Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group
Anan Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group

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

社会医療法人川島会 川島病院(徳島県)
社会医療法人川島会 川島透析クリニック(徳島県)
社会医療法人川島会 鴨島川島クリニック(徳島県)
社会医療法人川島会 鳴門川島クリニック(徳島県)
社会医療法人川島会 脇町川島クリニック(徳島県)
社会医療法人川島会 阿南川島クリニック(徳島県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

2016 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 17 Day

Last modified on

2018 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name