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 UMIN000021818
Receipt No. R000024962
Scientific Title Efficacy and safety of phosphate binders, ferric citrete hydrate and lanthunam carbohydrate, in patients undergoing maintenance hemodialysis
Date of disclosure of the study information 2016/04/07
Last modified on 2018/04/15

* 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 Efficacy and safety of phosphate binders, ferric citrete hydrate and lanthunam carbohydrate, in patients undergoing maintenance hemodialysis
Acronym Efficacy of phosphate binders
Scientific Title Efficacy and safety of phosphate binders, ferric citrete hydrate and lanthunam carbohydrate, in patients undergoing maintenance hemodialysis
Scientific Title:Acronym Efficacy of phosphate binders
Region
Japan

Condition
Condition Patients who are undergoing maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of ferric cytrate hydrate and lanthunam carbohydrate on serum phosphate,serum FGF23, dosage of ESA and iron metabolism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum FGF23 levels, dosage of ESA and iron metabolism
Key secondary outcomes Ca, P, and intact-PTH levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ferric citrate hydrate or sucroferric oxyhydroxide for 6 months
Interventions/Control_2 continue to take lanthanum hydrate carabonate
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
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) age > 19 years and < 86 years, (2) hemodialysis duration >2 years at enrollment, and (3) hyperphosphatemia that was treated with lanthanum carbonate at least 12 weeks before enrollment.
Key exclusion criteria (1) Active gastrointestinal hemorrhage,(2) malignant tumor, (3) liver cirrhosis and (4) hematological disorder.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyasu Otsuki
Organization Nihon University School of Medicine
Division name Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email totsuki16@gmail.com

Sponsor
Institute Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine
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
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 橋本みなみ内科本院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 07 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
2015 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 07 Day
Last modified on
2018 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.