UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002002 |
|---|---|
| Receipt number | 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 13:43:44 |
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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
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
shigeon@wakayama-med.ac.jp
Sponsor or person
Institute
Phosphate Research group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002439
