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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005483
Receipt No. R000006504
Official scientific title of the study Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Date of disclosure of the study information 2011/04/30
Last modified on 2011/07/21

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Basic information
Official scientific title of the study Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Title of the study (Brief title) Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Region
Japan

Condition
Condition end-stage renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the difference of vascular calcification between lanthanum carbonate and calcium carbonate administered group in hemodialysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Abdominal aortic calcification (Progression of abdominal aortic calcification volume detected by computed tomography image for renal carcinoma screening)
Key secondary outcomes 1) Phosphorus and calcium level achievement rate as defined by the Japanese Society for Dialysis Therapy guideline
2) Incidence of hypercalcemia ( defined as corrected serum calcium>10.5mg/dl)
3) Incidence of secondary hyperparathyroidism (defined as i-PTH>240pg/ml)
4) Performance rate of PTx and PEIT
5) BAP(ALP), i-PTH, BAP/i-PTH
6) Arterial stiffness change (CAVI, PWV, ABI)
7) Safety


In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lanthanum carbonate treatment (Enrollment: 1 year, Follow-up: 3 years, Extension period:
2 years)
Interventions/Control_2 Calcium carbonate treatment ((Enrollment: 1 year, Follow-up: 3 years, Extension period:
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Hemodialysis patients
2) SerumP>6.0mg/dl and taking Phosphate binder in Hyperphosphosphataemia.
3) Hemodialysis for more than 6 mo, less than 5 years
4) Men or women >=20 years of age
5) Patients with written IC

Key exclusion criteria 1) Contraindications to Ca carbonate and La carbonate
2) Severe GI disorders
3) History of obstructed bowels
4) History of IHD/stroke within 6 mo before randomization
5) Severe congestive heart failure
6) Severe liver dysfunction (AST or ALT greater than 3 times the upper limit of normal, hepatic cirrhosis)
7) Severe malnutrition
8) Malignancy of any type within the last five years
9) Severe infectious disease within 3 mo before randomization
10) Pregnant or possibly pregnant women and women on lactation
11) Ineligible patients according to the investigators judgment
Target sample size 300

Research contact person
Name of lead principal investigator Hiromichi Suzuki
Organization Saitama Medical School
Division name Department of Nephrology
Address 38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL +81-49-276-1612
Email

Public contact
Name of contact person Hiromichi Suzuki
Organization Saitama Medical School
Division name Department of Nephrology
Address 38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL +81-49-276-1612
Homepage URL
Email iromichi@saitama-med.ac.jp

Sponsor
Institute Department of Nephrology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Saitama Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 埼玉医科大学病院 入間台クリニック 岡病院 武蔵嵐山病院 くぼしまクリニック

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 30 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2011 Year 04 Month 21 Day
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2011 Year 04 Month 21 Day
Last modified on
2011 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006504


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