UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005483 |
|---|---|
| Receipt number | R000006504 |
| Scientific Title | Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients |
| Date of disclosure of the study information | 2011/04/30 |
| Last modified on | 2019/12/09 14:15:12 |
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Basic information
Public title
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Acronym
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Scientific Title
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Scientific Title:Acronym
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Region
| Japan |
Condition
Condition
end-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the difference of vascular calcification between lanthanum carbonate and calcium carbonate administered group in hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Abdominal aortic calcification (Progression of abdominal aortic calcification volume detected by computed tomography image for renal carcinoma screening)
Key secondary outcomes
1) Phosphorus and calcium level achievement rate as defined by the Japanese Society for Dialysis Therapy guideline
2) Incidence of hypercalcemia ( defined as corrected serum calcium>10.5mg/dl)
3) Incidence of secondary hyperparathyroidism (defined as i-PTH>240pg/ml)
4) Performance rate of PTx and PEIT
5) BAP(ALP), i-PTH, BAP/i-PTH
6) Arterial stiffness change (CAVI, PWV, ABI)
7) Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment (Enrollment: 1 year, Follow-up: 3 years, Extension period:
2 years)
Interventions/Control_2
Calcium carbonate treatment ((Enrollment: 1 year, Follow-up: 3 years, Extension period:
2 years)
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) Hemodialysis patients
2) SerumP>6.0mg/dl and taking Phosphate binder in Hyperphosphosphataemia.
3) Hemodialysis for more than 6 mo, less than 5 years
4) Men or women >=20 years of age
5) Patients with written IC
Key exclusion criteria
1) Contraindications to Ca carbonate and La carbonate
2) Severe GI disorders
3) History of obstructed bowels
4) History of IHD/stroke within 6 mo before randomization
5) Severe congestive heart failure
6) Severe liver dysfunction (AST or ALT greater than 3 times the upper limit of normal, hepatic cirrhosis)
7) Severe malnutrition
8) Malignancy of any type within the last five years
9) Severe infectious disease within 3 mo before randomization
10) Pregnant or possibly pregnant women and women on lactation
11) Ineligible patients according to the investigators judgment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Medical School
Division name
Department of Nephrology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
+81-49-276-1612
iromichi@saitama.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Medical School
Division name
Department of Nephrology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
+81-49-276-1612
Homepage URL
iromichi@saitama.ac.jp
Sponsor or person
Institute
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo, Moroyama-machi,Iruma-gun, Saitama
Tel
0492761354
hirb@saitama-med.ac.jp
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
埼玉医科大学病院 入間台クリニック 岡病院 武蔵嵐山病院 くぼしまクリニック
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Information other than what is described on this site is not open to the public.
Publication of results
Unpublished
Result
URL related to results and publications
Information other than what is described on this site is not open to the public.
Number of participants that the trial has enrolled
Results
No result
Results date posted
| 2019 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No participants
Participant flow
No participants
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 21 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006504
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