UMIN-CTR Clinical Trial

Basic information
Public title	Therapeutic efficacy of magnesium oxide for peripheral artery disease among patients undergoing hemodialysis - Open label randomized controlled trial
Acronym	Therapeutic efficacy of magnesium oxide for peripheral artery disease
Scientific Title	Therapeutic efficacy of magnesium oxide for peripheral artery disease among patients undergoing hemodialysis - Open label randomized controlled trial
Scientific Title:Acronym	Therapeutic efficacy of magnesium oxide for peripheral artery disease
Region	Japan

Condition
Condition	Peripheral artery disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate therapeutic efficacy of magnesium oxide on peripheral artery disease of patients undergoing hemodialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	skin perfusion pressure
Key secondary outcomes	ankle brachial index capillary analysis system bone turnover markers (bone alkaline phosphatase, TRACP-5b, parathyroid hormone)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention group: Magnesium oxide Administration period: 12 months Target range of serum magnesium levels: 2.7-3.3 mg/dL
Interventions/Control_2	no treatment
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 undergoing maintenance hemodialysis/hemodiafiltration and aged 20 years or older. 2. Patients with SPP of less than 80 mmHg. 3. Patients with gastroduodenal ulcer and/or gastritis and/or dyspepsia.
Key exclusion criteria	1. Patients with serum magnesium levels of 3.4 mg/dL or greater. 2. Patients who had experienced side effects by magnesium oxide or rebamipide. 3. Patients currently taking magnesium oxide. 4. Patients suffering from critical limb ischemia. 5. Patients currently taking part in other interventional studies.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayuki Hamano
Organization	Osaka University Graduate School of Medicine
Division name	Department of Comprehensive Kidney Disease Research
Zip code
Address	2-2, Yamada-oka, Suita, Japan
TEL	0668793857
Email	hamatea@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Sakaguchi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Comprehensive Kidney Disease Research
Zip code
Address	2-2, Yamada-oka, Suita, Japan
TEL	0668793857
Homepage URL
Email	yusuke7771@gmail.com

Sponsor
Institute	Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
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
Email

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	医療法人 徳靖会 小尾クリニック 医療法人 和光会 橋中診療所

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 15 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	2017 Year 01 Month 11 Day
Date of IRB	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 01 Month 11 Day
Last follow-up date	2019 Year 10 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2019 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027949