UMIN-CTR Clinical Trial

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

Japan

Condition

chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

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.

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

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

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.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Daijo Inaguma

Organization

Fujita Health University

Division name

Department of Nephrology

Zip code

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-9245

Email

daijo@fujita-hu.ac.jp

Name of contact person

1st name
Middle name
Last name	Daijo Inaguma

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

Email

daijo@fujita-hu.ac.jp

Institute

Fujita Health University

Institute

Department

Personal name

Organization

Clinical research support center of Fujita Health University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤田保健衛生大学病院

Date of disclosure of the study information

2018

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

21

Day

Last modified on

2017

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034815