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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002002
Receipt No. R000002439
Scientific Title Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).
Date of disclosure of the study information 2009/05/25
Last modified on 2014/05/24

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Basic information
Public title Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).
Acronym STudy Of hyperPhosphatemia in CKD5D patients undergoing HemoDialysis (STOP-HD).
Scientific Title Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).
Scientific Title:Acronym STudy Of hyperPhosphatemia in CKD5D patients undergoing HemoDialysis (STOP-HD).
Region
Japan

Condition
Condition Hemodialysis patients with hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 #Evaluate the treatment trend of La carbonate for CKD5D patients with hyperphospatemia
#Assess the influence of the aortic calcification index (ACI) after Lanthanum carbonate treatment on prognostic events
Basic objectives2 Others
Basic objectives -Others Relationship between clinical course and time dependent change/prognosis of (aortic calcification index) ACI score.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes #Treatment status of phosphate binders and VitaminD
#Measure aortic calcification (ACI) at baseline and after the treatment of La carbonate (maximum 5 years).
Key secondary outcomes P,Ca, intact-PTH, Alb, Lipid, CRP, hepatic function, CTR, nPCR, vital sign, safety and tolerability at baseline and after the treatment of La carbonate (maximum 5 years).

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lanthanum carbonate 250-750mg will be administered orally three times daily after meals for 5 years.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) CKD5D patients undergoing HemoDialysis, Age >=20
2) Patients who can receive La carbonate treatment
3) Patients who undergo hemodialysis between 3 months and 10 years
4) Possible long term observation patients
5) Patients with written IC (Informed Consent)
Key exclusion criteria 1) Patients with cancer or suspicious for cancer
2) Pregnant or possibly pregnant patients, patients on lactation
3) Patients who meet the contraindiation criteria in package insert of Lanthanum carbonate
4) Inappropriate patients for this study according to the investigator's judgment
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Professor Takashi Shigematsu
Organization Wakayama Medical University
Division name Division of Nephrology & Blood Purification Medicine
Zip code
Address 811-1, Kimiidera, Wakayama city, 641-8510, Wakayama, Japan
TEL 073-447-2300
Email

Public contact
Name of contact person
1st name
Middle name
Last name Associate Professor, Shigeo Negi
Organization Wakayama Medical University
Division name Division of Nephrology & Blood Purification Medicine
Zip code
Address 811-1, Kimiidera, Wakayama city, 641-8510, Wakayama, Japan
TEL
Homepage URL
Email shigeon@wakayama-med.ac.jp

Sponsor
Institute Phosphate Research group
Institute
Department

Funding Source
Organization The Waksman foundation of Japan inc.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2009 Year 05 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 Completed
Date of protocol fixation
2009 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
2015 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 24 Day
Last modified on
2014 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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