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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023657
Receipt No. 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

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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
Institute Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Institute
Department

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
URL(English) https://upload.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


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