UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002820 |
|---|---|
| Receipt number | R000003435 |
| Scientific Title | Evaluation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients on dialysis with either 2.5 or 3.0 mEq/L of dialysate calcium concentration |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2009/12/01 16:26:48 |
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Basic information
Public title
Evaluation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients on dialysis with either 2.5 or 3.0 mEq/L of dialysate calcium concentration
Acronym
Evaluation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients with either 2.5 or 3.0 mEq/L of dialysate calcium concentration
Scientific Title
Evaluation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients on dialysis with either 2.5 or 3.0 mEq/L of dialysate calcium concentration
Scientific Title:Acronym
Evaluation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients with either 2.5 or 3.0 mEq/L of dialysate calcium concentration
Region
| Japan |
Condition
Condition
Maintenance hemodialysis patients with hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of lanthanum carbonate in hyperphosphatemia patients on dialysis with with either 2.5 or 3.0 mEq/L of dialysate calcium concentration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Serum phosphate, serum calcium and serum Ca x P product level and intact-PTH
Key secondary outcomes
Adverse events, drug compliance
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 treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hemodialysis pts
2) Hyperphosphatemia pts treated with phosphate binder or hyperphosphatemia pts needed to start phosphate binder treatment
Key exclusion criteria
1) Pts who meet the contraindiation criteria in package insert of lanthanum carbonate
2) Pregnant or possibly pregnant pts, pts on lactation
3) Inappropriate pts for this study according to the investigator's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihiro Kondo |
Organization
Rakuwakai Otowa Kinen Hospital
Division name
Department of Neprology
Zip code
Address
29-1 Chinjyucho, Koyama, Yamashina, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamamoto |
Organization
Rakuwakai Otowa Kinen Hospital
Division name
Department of Neprology
Zip code
Address
29-1 Chinjyucho, Koyama, Yamashina, Kyoto
TEL
075-594-8010
Homepage URL
Sponsor or person
Institute
Rakuwakai Otowa Kinen Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
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
洛和会音羽記念病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 01 | Day |
Last modified on
| 2009 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003435
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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