UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006815 |
|---|---|
| Receipt number | R000008048 |
| Scientific Title | Outcome study of Lanthanum Carbonate compared with Calcium carbonate on cardiovascular mortality and morbidity in patients with chronic kidney disease on hemodialysis: Landmark Study |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2020/11/27 14:14:34 |
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Basic information
Public title
Outcome study of Lanthanum Carbonate compared with Calcium carbonate on cardiovascular mortality and morbidity in patients with chronic kidney disease on hemodialysis: Landmark Study
Acronym
Outcome study of Lanthanum Carbonate compared with Calcium carbonate in hemodialysis patients: Landmark Study
Scientific Title
Outcome study of Lanthanum Carbonate compared with Calcium carbonate on cardiovascular mortality and morbidity in patients with chronic kidney disease on hemodialysis: Landmark Study
Scientific Title:Acronym
Outcome study of Lanthanum Carbonate compared with Calcium carbonate in hemodialysis patients: Landmark Study
Region
| Japan |
Condition
Condition
Hemodialysis patients with hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum Carbonate compared with those with Calcium Carbonate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Cardiovascular event free survival time
Following diseases were recognized;
1) death due to cardiovascular diseases including sudden cardiac death
2) nonfatal myocardial infarction
3) nonfatal cerebral stroke including transient ischemic attack, TIA
4) unstable angina
5) hospitalization for heart failure
6) hospitalization for ventricular arrhythmia
Key secondary outcomes
- overall survival
- secondary hyperparathyroidism free survival
- hip fracture free survival
- quality of life questionnaire (KDQOL-SF, v1.3)
- bone mineral density (DEXA)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment (Patients will be followed for three years after the last patient is enrolled )
Interventions/Control_2
Calcium carbonate treatment (Patients will be followed for three years after the last patient is enrolled )
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
- hemodialysis patients with hyperphosphatemia who require phosphate binders
- hemodialysis for more than 3 months
- patients who have at lease one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)
- intact-PTH < or =240 pg/mL
- life expectancy > 1 year
- with written informed consent
Key exclusion criteria
- contraindications to Ca carbonate and La carbonate
- swallowing disorders
- severe GI disorders
- history of obstructed bowels
- history of IHD/stroke within 6 months
- NYHA classification III-IV
- severe liver dysfunction, AST or ALT greater than 3 times the upper limit of institution
- require treatment of arrthythmia
- severe malnutrition
- malignancy of any type within the last 5 years
- peritoneal dialysis patients
- pregnant or possibly pregnant women or women on lactation and plan to get pregnant within study term
- ineligible patients according to the investigator's judgment
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Akizawa |
Organization
Showa University
Division name
Division of Nephrology, Department of Medicine
Zip code
1428555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
+81-3-3784-8000
akizawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ogata |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Internal Medicine
Zip code
2248503
Address
35-1 Chigasakichuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL
+81-45-949-7000
Homepage URL
ogatah@med.showa-u.ac.jp
Sponsor or person
Institute
Landmark Study Group
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Foundation for Biomedical Research and Innovation at Kobe
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Clinical Trials Review Committee
Address
Hatanodai 1-5-8, Shinagawa, Tokyo, Japan
Tel
+81-3-3784-8000
ctsc.admin@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01578200
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2347
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
| 2011 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 02 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 02 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 01 | Day |
Last modified on
| 2020 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008048
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