UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035527
Receipt number R000040476
Scientific Title Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Date of disclosure of the study information 2019/01/13
Last modified on 2022/03/22 20:47:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia

Acronym

Lanthanum Versus Calcium Carbonate for Patients With CKD

Scientific Title

Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia

Scientific Title:Acronym

Lanthanum Versus Calcium Carbonate for Patients With CKD

Region

Japan


Condition

Condition

pre-dialysis CKD

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Coronary artery calcification score [ Time Frame: 1 year ]

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Active Comparator: Calcium carbonate
Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day.

Interventions/Control_2

Experimental: Lanthanum carbonate
Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) 20 Years and older (2) Hyperphosphatemia (For patients without calcium carbonate, 4.5- mg/dL) (For Patients with calcium carbonate, 4.0- mg/dL) (3) With written informed consent

Key exclusion criteria

(1) History of cardiac surgery and/or coronary artery stenting (2) Polycystic kidney disease (3) Hypothyroidism (4) On treatment with lanthanum carbonate (5) History of admission within 3 months (6) History of ileus (7) Severe gastrointestinal dysfunction (8) Severe liver dysfunction (9) Allergy to lanthanum carbonate or calcium carbonate (10) Pregnant or breastfeeding women (11) Judged as ineligible by primary physicians

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Sakaguchi
Middle name
Last name Yusuke

Organization

Osaka University Hospital

Division name

Department of Nephrology

Zip code

565-0871

Address

2-15, Yamada-oka, Suita, Osaka

TEL

06-6879-3857

Email

sakaguchi@kid.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Sakaguchi
Middle name
Last name Yusuke

Organization

Osaka University Hospital

Division name

Department of Nephrology

Zip code

565-0871

Address

2-15, Yamada-oka, Suita, Osaka

TEL

06-6879-3857

Homepage URL


Email

sakaguchi@kid.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Nephrology, Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

This study is funded by Bayer Yakuhin, Ltd

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

Osaka University

Address

2-15, Yamada-oka, Suita, Osaka

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02237534

Org. issuing International ID_1

ClinicalTrials.gov Identifier

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 13 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

Completed

Date of protocol fixation

2014 Year 06 Month 02 Day

Date of IRB

2014 Year 06 Month 02 Day

Anticipated trial start date

2014 Year 06 Month 02 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 12 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name