UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004814 |
|---|---|
| Receipt number | R000003241 |
| Scientific Title | Effect of Intravenous Saccharated Ferric Oxide on Serum FGF23 and Mineral Metabolism in Hemodialysis Patients |
| Date of disclosure of the study information | 2011/01/03 |
| Last modified on | 2011/01/03 15:34:52 |
* 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
Effect of Intravenous Saccharated Ferric Oxide on Serum FGF23 and Mineral Metabolism in Hemodialysis Patients
Acronym
Saccharated ferric oxide and FGF23
Scientific Title
Effect of Intravenous Saccharated Ferric Oxide on Serum FGF23 and Mineral Metabolism in Hemodialysis Patients
Scientific Title:Acronym
Saccharated ferric oxide and FGF23
Region
| Japan |
Condition
Condition
Hemodialysis patients with iron-deficiency anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Intravenous Saccharated Ferric Oxide on Serum FGF23 and Mineral Metabolism in Hemodialysis Patients.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of FGF23, and Mineral metabolism
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
saccharated ferric oxide dosage
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The dialysis outpatient who takes less than Hb 10.5g/dl, less than Ferritin 100 ng/ml, 3 times a week dialysis and more than three months in a dialysis carrer.
Key exclusion criteria
exclude a patient with menstruation, active gastrointestinal hemorrhage, tumor-bearing, hematological disorder, hepatitis and liver cirrhosis, secondary hyperparathyroidism (intact parathyroid hormon more than 500 pg/ml), parathyroidectomy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeda Yoko |
Organization
Kobe University School of Medicine
Division name
nephrology and kidney center
Zip code
Address
7-5-2, kusunoki-cyo, Cyuou-ku, Kobe
TEL
078-382-6500
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University School of Medicine
Division name
nephrology and kidney center
Zip code
Address
TEL
078-382-6500
Homepage URL
Sponsor or person
Institute
kobe university school of medicine, division of nephrology and kidney center
Institute
Department
Personal name
Funding Source
Organization
Kobe Parathyroid and Bone Forum
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 01 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 03 | Day |
Last modified on
| 2011 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003241
