UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024275
Receipt No. R000027949
Scientific Title Therapeutic efficacy of magnesium oxide for peripheral artery disease among patients undergoing hemodialysis - Open label randomized controlled trial
Date of disclosure of the study information 2016/12/15
Last modified on 2019/10/06

* 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 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/ctr_e/ctr_view.cgi?recptno=R000027949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.