Unique ID issued by UMIN | UMIN000006816 |
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Receipt number | R000008049 |
Scientific Title | Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study |
Date of disclosure of the study information | 2011/12/01 |
Last modified on | 2018/06/10 11:37:54 |
Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study
Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS
Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study
Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS
Japan |
Hemodialysis patients with hyperphosphatemia
Nephrology |
Others
NO
To compare the effect of coronary artery calcification between lanthanum carbonate and calcium carbonate in hemodialysis patients with hyperphosphatemia
Efficacy
Confirmatory
Pragmatic
Phase III
Change in coronary artery calcification score (Agatston Score) by MDCT for 2 years
-Percent change from baseline in Agatston Score
- Change in serum phosphate
- Change in serum adjusted calcium
- Change oin intact-PTH
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Lanthanum carbonate treatment (Follow-up: 2 years)
Calcium carbonate treatment (Follow-up: 2 years)
Not applicable |
Not applicable |
Male and Female
- 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
- 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
400
1st name | |
Middle name | |
Last name | Tadao Akizawa |
Showa University
Division of Nephrology, Department of Medicine
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
+81-3-3784-8000
akizawa@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroaki Ogata |
Showa University Northern Yokohama Hospital
Department of Internal Medicine
35-1 Chigasakichuo, Tsuzuki, Yokohama, Kanagawa, Japan
+81-45-949-7000
ogatah@med.showa-u.ac.jp
Landmark Study Group
Bayer Yakuhin, Ltd.
Profit organization
Japan
Foundation for Biomedical Research and Innovation at Kobe
YES
NCT05178200
ClinicalTrials.gov
2011 | Year | 12 | Month | 01 | Day |
Published
Main results already published
2011 | Year | 10 | Month | 17 | Day |
2011 | Year | 11 | Month | 01 | Day |
2017 | Year | 05 | Month | 31 | Day |
2017 | Year | 06 | Month | 02 | Day |
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 07 | Month | 31 | Day |
2011 | Year | 12 | Month | 01 | Day |
2018 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008049
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