UMIN-CTR 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 |
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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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000040476
