UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010730
Receipt number R000012538
Scientific Title Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients
Date of disclosure of the study information 2013/05/15
Last modified on 2018/11/19 16:41:41

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Basic information

Public title

Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients

Acronym

Effect of lanthanum carbonate on serum levels of fetuin-A in hemodialysis patients

Scientific Title

Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients

Scientific Title:Acronym

Effect of lanthanum carbonate on serum levels of fetuin-A in hemodialysis patients

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is designed to investigate the effect of lanthanum carbonate treatment on serum fetuin-A concentrations in hemodialyasis patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

serum fetuin-A concentration

Key secondary outcomes

serum FGF-23 concentration
safety evaluation


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lanthanum carbonate administration

Interventions/Control_2


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

20 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Hemodialysis patient
Hyperphosphatemia patient

Key exclusion criteria

Lanthanum carbonate contraindication
After parathyroidectomy
Peritoneal dialysis patient
Digestive tract disease patient
Liver dysfunction patient
Pregnant woman

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name hideyasu matsuyama

Organization

Yamaguchi university

Division name

Department of urology

Zip code


Address

1-1-1,minamikogushi , ube city, yamaguchi prefer,japan

TEL

0836-22-2275

Email

hidde@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideyasu Matsuyama

Organization

Yamaguchi University Hospital

Division name

Department of urology

Zip code


Address

Ube

TEL

0836222275

Homepage URL


Email

hidde@yamaguchi-u.ac.jp


Sponsor or person

Institute

Department of urology, school of medicine,yamaguchi university

Institute

Department

Personal name



Funding Source

Organization

Bayer health care

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2013 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 05 Month 15 Day

Last modified on

2018 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012538


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name