Unique ID issued by UMIN | UMIN000002481 |
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Receipt number | R000002985 |
Scientific Title | Investigation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients treated with cinacalcet hydrochloride |
Date of disclosure of the study information | 2009/09/11 |
Last modified on | 2010/08/27 10:54:04 |
Investigation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients treated with cinacalcet hydrochloride
Investigation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients treated with cinacalcet hydrochloride
Investigation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients treated with cinacalcet hydrochloride
Investigation of efficacy and safety of lanthanum carbonate in hyperphosphatemia patients treated with cinacalcet hydrochloride
Japan |
Hyperphosphatemia patients treated with cinacalcet hydrochloride for secondary hyperparathyroidism
Nephrology |
Others
NO
To investigate efficacy and safety of lanthanum carbonate in hyperphosphatemia patients on dialysis treated with cinacalcet hydrochrolide for secondary hyperparathyroidism
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Serum phosphate level
1. Corrected serum calcium, serum calcium phosphorus product, intact PTH
2. Adverse events
3. Drug compliance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Treatment of hyperphosphatemia with lanthanum carbonate for 3 months
Not applicable |
Not applicable |
Male and Female
1) Hemodialysis pts
2) Secondary hyperparathyroidism pts treated with cinacalcet
3) Sevelamer monotherapy failure, sevelamer combined with calcium carbonate treatment failure (P > 6.0 mg/dL) or poor compliance of sevelamer
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
10
1st name | |
Middle name | |
Last name | Katsuhiko Arimoto |
Shigei medical research hospital
Internal medicine, institute of kidney disease
2117, Yamada, Okayama-city, Okayama
086-282-5311
1st name | |
Middle name | |
Last name | Katsuhiko Arimoto |
Shigei medical research hospital
Internal medicine, institute of kidney disease
2117, Yamada, Okayama-city, Okayama
086-282-5311
Shigei medical research hospital
None
Self funding
NO
重井医学研究所附属病院
2009 | Year | 09 | Month | 11 | Day |
Unpublished
Completed
2009 | Year | 06 | Month | 16 | Day |
2009 | Year | 06 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2009 | Year | 09 | Month | 11 | Day |
2010 | Year | 08 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002985
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