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
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
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
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
