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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
