A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

KDL Inc.

ClinicalTrials.gov Identifier:

NCT01039428

First received: December 24, 2009

Last updated: June 5, 2012

Last verified: May 2012

History of Changes

Results First Received: February 29, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Hyperphosphatemia Chronic Kidney Disease
Interventions:	Dietary Supplement: HS219 Dietary Supplement: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
HS219	Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Placebo	Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.

Participant Flow: Overall Study

	HS219	Placebo
STARTED	35	28
COMPLETED	33	28
NOT COMPLETED	2	0
Protocol Violation	1	0
Withdrawal by Subject	1	0

Baseline Characteristics

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Reporting Groups

	Description
HS219	Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Placebo	Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
Total	Total of all reporting groups

Baseline Measures

	HS219	Placebo	Total
Number of Participants [units: participants]	35	28	63
Age [units: years] Mean ± Standard Deviation	57.1 ± 11.0	55.7 ± 11.3	56.4 ± 11.0
Gender [units: participants]
Female	24	19	43
Male	11	9	20

Outcome Measures

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1. Primary:

Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline [ Time Frame: baseline and end of the chewing treatment during three week treatment period ]

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2. Secondary:

Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL [ Time Frame: baseline and end of the treatment ]

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3. Secondary:

Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3 [ Time Frame: week 3 ]

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4. Secondary:

Serum Inorganic Phosphorus Level [ Time Frame: week 3 ]

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5. Secondary:

Salivary Inorganic Phosphorus Level [ Time Frame: week 3 ]

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6. Secondary:

Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL]) [ Time Frame: week 3 ]

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7. Secondary:

Ca×P [ Time Frame: week 3 ]

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8. Secondary:

Serum Intact Parathyroid Hormone (PTH) Level [ Time Frame: week 3 ]

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9. Secondary:

Serum Intact Fibroblast Growth Factor (FGF) 23 Level [ Time Frame: week 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: KDL
phone: 818058844243
e-mail: toiawase@advance-cro.co.jp

No publications provided

Responsible Party:	KDL Inc.
ClinicalTrials.gov Identifier:	NCT01039428 History of Changes
Other Study ID Numbers:	HS219CCR-001
Study First Received:	December 24, 2009
Results First Received:	February 29, 2012
Last Updated:	June 5, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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