UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034640 |
|---|---|
| Receipt number | R000039494 |
| Scientific Title | The effect of sucroferric oxyhydroxide starting from a small amount |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2020/02/13 11:17:45 |
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Basic information
Public title
The effect of sucroferric oxyhydroxide starting from a small amount
Acronym
The effect of sucroferric oxyhydroxide starting from a small amount
Scientific Title
The effect of sucroferric oxyhydroxide starting from a small amount
Scientific Title:Acronym
The effect of sucroferric oxyhydroxide starting from a small amount
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of sucroferric oxyhydroxide starting from a small amount
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of side effects of sucroferric oxyhydroxide and the transition of serum phosphorus level
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
hemodialysis patients with secondary hyperparathyroidism in our hospital outpatient clinic
Key exclusion criteria
Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
048-792-1811
kuwahara@k-naika-cl.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
048-792-1811
Homepage URL
kuwahara@k-naika-cl.jp
Sponsor or person
Institute
Saitama Tsukinomori Clinic
Institute
Department
Personal name
Funding Source
Organization
Saitama Tsukinomori Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Saitama Tsukinomori Clinic
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
Tel
0487921811
kuwahara@k-naika-cl.jp
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
| 2018 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a prospective observational study of hemodialysis patients. The study was started for patients who are visiting our hospital. In this study, we planned to start with small doses of sucroferric oxyhydroxide and gradually increase the dose to minimize the onset of gastrointestinal side effects. However, 1) the informed consent was obtained from only nine patients, 2) two patients were discontinued due to difficulty in taking the drug, and 3) two patients discontinued the administration due to the side effects of constipation or diarrhea even with a small dose. Therefore, the study was canceled because the number of participants could not be secured for the study.
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039494
