UMIN-CTR Clinical Trial

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
Email	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
Email	kuwahara@k-naika-cl.jp

Sponsor
Institute	Saitama Tsukinomori Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039494