UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023700 |
|---|---|
| Receipt number | R000027276 |
| Scientific Title | Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/08/20 09:32:21 |
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Basic information
Public title
Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Acronym
Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Scientific Title
Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Scientific Title:Acronym
Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the evaluation for the effectiveness, safety, and the effect on anemia, iron, CKD-MBD related factors of iron containing phosphate binder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events (cerebral cardiovascular disease, infection, hospitalization) and survival.
Key secondary outcomes
The effect of iron containing phosphate binder on the anemia (Hb, Ret, RDW,dose of iron and ESA), iron metabolism(ferritin, TSAT, hepcidin, NTBI), CKD-MBD(Ca, P, FGF23,dose of phosphate binder, vitaminD, cinacalcet), arteriosclerosis (PWV, ABI, TMAO, LVMI), and microbiome.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012), treated with iron containing phosphate binder for 3 year.
Interventions/Control_2
According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012),treated with non iron containing phosphate binder for 3 year.
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
Maintenance hemodialysis patient with high serum phosphate level.
Key exclusion criteria
1) Patients who received maintenance hemodialysis for < 6month.
2) Patients with severe heart failure (>NYHA III), respiratory failure, malignancy disease, or severe liver dysfunction.
3) Patient with high serum ferritin level(>100 ng/mL) at the start of this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Kidney and dialysis
Zip code
Address
1-1, Mukogawa cho, Nishinomiya
TEL
0798-45-6521
jin@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kuragano |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Kidney and dialysis
Zip code
Address
1-1, Mukogawa cho, Nishinomiya
TEL
0798-45-6521
Homepage URL
kuragano@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Date of protocol fixation
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | 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 | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027276
