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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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 ]

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

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

4.  Secondary:   Serum Inorganic Phosphorus Level   [ Time Frame: week 3 ]

5.  Secondary:   Salivary Inorganic Phosphorus Level   [ Time Frame: week 3 ]

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 ]

7.  Secondary:   Ca×P   [ Time Frame: week 3 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


No publications provided by KDL Inc.

Publications automatically indexed to this study:

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