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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000030503 |
Receipt No. | R000034815 |
Scientific Title | The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23 |
Date of disclosure of the study information | 2018/01/20 |
Last modified on | 2017/12/21 |
Basic information | ||
Public title | The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23 | |
Acronym | CVD-LAF study | |
Scientific Title | The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23 | |
Scientific Title:Acronym | CVD-LAF study | |
Region |
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Condition | ||
Condition | chronic kidney disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The objective is to investigate the effect of usual amount of active form of vitamin D in clinical situation with or without lanthanum carbonate for serum FGF23 level and cardiovascular system. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | change of serum FGF23 level after 24 weeks |
Key secondary outcomes | changes of laboratory data including other bone metabolic markers, results of echocardiogram, changes of aortic calcification score, amounts of active form of vitamin D or lanthanum carbonate |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The period of treatment of patients randomized to active form of vitamin D group is 52 weeks.
The initial dose of active form of vitamin D, which is alphacalcidol, is 0.25 microgram/day or 0.5 microgram/day, if serum corrected calcium concentration is from 9.0 to 9.5 mg/dl, or less than 9.0 mg/dl, respectively. Investigators control dose of alphacalcidol to set serum corrected calcium level to >=8.5 mg/dl and < 10.0 mg/dl. |
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Interventions/Control_2 | The period of treatment of patients randomized to combination of active form of vitamin D and lanthanum carbonate group is 52 weeks.
The initial dose of active form of vitamin D, which is alphacalcidol, is 0.25 microgram/day or 0.5 microgram/day, if serum corrected calcium concentration is from 9.0 to 9.5 mg/dl, or less than 9.0 mg/dl, respectively. Moreover the initial dose of lanthanum carbonate is 750 mg/day. Investigators control dose of alphacalcidol to set serum corrected calcium level to >=8.5 mg/dl and <10.0 mg/dl. In addition, investigators control dose of lanthanum carbonate to set serum phosphate level to >=3.5 mg/dl and < 6.0 mg/dl. |
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Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | We include patients who meet conditions below:
1. eGFR is >=10 and < 45 ml/min/1.73m2 2. serum corrected calcium level is less than 9.5 mg/dL 3. serum phosphate level is >=4 and < 6 mg/dL 4. serum intact PTH level is >=60 pg/mL |
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Key exclusion criteria | We exclude patients who meet conditions below:
1. patients who have taken active form of vitamin D within 4 weeks. 2. patients who have taken any supplements including natural form of vitamin D within 4 weeks. 3. patients who have taken any phosphate binders within 4 weeks. 4. patients who do not agree with the study 5. patients whom one or more investigators do not regard as appropriate. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Fujita Health University | ||||||
Division name | Department of Nephrology | ||||||
Zip code | |||||||
Address | 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi | ||||||
TEL | 0562-93-9245 | ||||||
daijo@fujita-hu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Fujita Health University | ||||||
Division name | Department of Nephrology | ||||||
Zip code | |||||||
Address | 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi | ||||||
TEL | 0562-93-9245 | ||||||
Homepage URL | |||||||
daijo@fujita-hu.ac.jp |
Sponsor | |
Institute | Fujita Health University |
Institute | |
Department |
Funding Source | |
Organization | Clinical research support center of Fujita Health University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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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 | 藤田保健衛生大学病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034815 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |