UMIN-CTR Clinical Trial

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

Hemodialysis patients with hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Healthserve

Institute

Department

Personal name

Organization

Healthserve

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2009

Year

12

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

12

Month

03

Day

Last modified on

2012

Year

03

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003465