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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002840
Receipt No. R000003465
Scientific Title Multicenter, randomized, placebo- controlled, double blind study of HS219 to evaluate the efficacy and safety in chronic kidney disease patients on hemodialysis with hyperphosphatemia
Date of disclosure of the study information 2009/12/07
Last modified on 2012/03/02

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Basic information
Public title Multicenter, randomized, placebo- controlled, double blind study of HS219 to evaluate the efficacy and safety in chronic kidney disease patients on hemodialysis with hyperphosphatemia
Acronym Study of HS219 in chronic kidney disease patients on hemodialysis with hyperphosphatemia
Scientific Title Multicenter, randomized, placebo- controlled, double blind study of HS219 to evaluate the efficacy and safety in chronic kidney disease patients on hemodialysis with hyperphosphatemia
Scientific Title:Acronym Study of HS219 in chronic kidney disease patients on hemodialysis with hyperphosphatemia
Region
Japan

Condition
Condition Hemodialysis patients with hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of HS219 when given three times a day
for 21 days to the hemodialysis patients with hyperphosphatemia who are not well controlled with calcium carbonate or sevelamer hydrogen chloride.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum phosphate change compared to placebo from baseline to day 21 when measured prior to hemodialysis at the maximum intervals.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 HS219
Interventions/Control_2 Placebo
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. Written consent is at age 20 years or over
2. On a stable hemodialysis regimen (at least 3 x per week) for >= 3 months prior to informed consent
3. Subject receiving calcium carbonate or sevelamer hydrochloride alone as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to informed consent
4. A mean value of the latest three serum phosphate levels before hemodialysis at the maximum intervals is > 5.5 mg/dL and < 9.0 mg/dL
Key exclusion criteria 1. Blood purification therapy other than hemodialysis
2. Current clinically significant intestinal motility disorder
3. Possible parathyroid intervention during the study period
4. History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
5. Receipt of any investigational drug within 30 days of informed consent
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Akizawa/ Masafumi Fukagawa
Organization Showa University School of Medicine/Tokai University School of Medicine
Division name Division of Nephrology,Department of Medicine/Division of Nephrology and Metabolism
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo/143 Shimokasuya, Isehara, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Advance CRO Co.,Ltd.
Division name Department of Clinical Study
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Healthserve
Institute
Department

Funding Source
Organization Healthserve
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 ・医療法人住吉クリニック 住吉クリニック病院(茨城県)
・特定医療法人丸山会 丸子中央総合病院(長野県)
・古河赤十字病院(茨城県)
・総合病院 土浦協同病院(茨城県)
・諏訪赤十字病院(長野県)
・総合病院 取手協同病院(茨城県)
・総合病院 国保旭中央病院(千葉県)
・医療法人社団偕翔会 駒込共立クリニック(東京都)
・医療法人社団白水会 須田クリニック(東京都)
・医療法人社団 昇陽会 阿佐谷すずき診療所(東京都)
・医療法人明陽会 明陽クリニック(愛知県)
・医療法人偕行会 名港共立クリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 07 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
Sixty eight HD patients maintained on calcium carbonate (33 subjects) or sevelamer (35 subjects) were enrolled during January - April, 2010. Sixty-three patients chewed at least one gum: 35 HS219 and 28 placebo. HS219 was well tolerated and safe. However, no significant effect of HS219 on reduction of serum phosphorous was observed. There were no significant differences between HS219 and placebo in the ratio of 1.5 mg/dL of reduction of serum phosphorus level and the rate of achievement to the targeted serum phosphorus level; &#8805; 3.5 mg/dL and < 5.5 mg/dL. There were no significant effects of HS219 on change of salivary phosphorus, serum Ca, serum Ca x P, iPTH and EGF 23.
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
2009 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 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
2009 Year 12 Month 03 Day
Last modified on
2012 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003465

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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