UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006816
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

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Basic information

Public 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

Acronym

Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS

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

Scientific Title:Acronym

Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS

Region

Japan


Condition

Condition

Hemodialysis patients with hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of coronary artery calcification between lanthanum carbonate and calcium carbonate in hemodialysis patients with hyperphosphatemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Change in coronary artery calcification score (Agatston Score) by MDCT for 2 years

Key secondary outcomes

-Percent change from baseline in Agatston Score
- Change in serum phosphate
- Change in serum adjusted calcium
- Change oin intact-PTH


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lanthanum carbonate treatment (Follow-up: 2 years)

Interventions/Control_2

Calcium carbonate treatment (Follow-up: 2 years)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

- 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

Key exclusion criteria

- 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

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadao Akizawa

Organization

Showa University

Division name

Division of Nephrology, Department of Medicine

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

+81-3-3784-8000

Email

akizawa@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ogata

Organization

Showa University Northern Yokohama Hospital

Division name

Department of Internal Medicine

Zip code


Address

35-1 Chigasakichuo, Tsuzuki, Yokohama, Kanagawa, Japan

TEL

+81-45-949-7000

Homepage URL


Email

ogatah@med.showa-u.ac.jp


Sponsor or person

Institute

Landmark Study Group

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Foundation for Biomedical Research and Innovation at Kobe

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT05178200

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2011 Year 10 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2017 Year 05 Month 31 Day

Date of closure to data entry

2017 Year 06 Month 02 Day

Date trial data considered complete

2017 Year 07 Month 04 Day

Date analysis concluded

2017 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2018 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name