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A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01464190
First received: September 12, 2011
Last updated: March 3, 2014
Last verified: March 2014
Results First Received: December 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Kidney Disease Requiring Chronic Dialysis
Interventions: Drug: PA21 (2.5 g tablet containing 500 mg iron)
Drug: Sevelamer carbonate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PA21 PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
Sevelamer Carbonate Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Participant Flow:   Overall Study
    PA21     Sevelamer Carbonate  
STARTED     391     268  
COMPLETED     322     227  
NOT COMPLETED     69     41  



  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.
For baseline characteristics, data from All Randomised patients was used.

Reporting Groups
  Description
PA21 PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Sevelamer Carbonate Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
Total Total of all reporting groups

Baseline Measures
    PA21     Sevelamer Carbonate     Total  
Number of Participants  
[units: participants]
  391     268     659  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 13.20     55.6  ± 14.58     55.4  ± 13.77  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     296     190     486  
>=65 years     95     78     173  
Gender  
[units: participants]
     
Female     171     102     273  
Male     220     166     386  
Region of Enrollment  
[units: participants]
     
United States     154     133     287  
Europe     85     49     134  
Croatia     16     8     24  
Russian Federation     65     44     109  
Serbia     37     18     55  
Ukraine     32     15     47  
South Africa     2     1     3  



  Outcome Measures
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1.  Primary:   Change From Baseline and Levels at Each Time Point for Serum Phosphorus   [ Time Frame: Every 4 weeks from baseline to Week 28 ]

2.  Primary:   Change From Baseline and Levels at Each Time Point for Serum Calcium   [ Time Frame: Every 4 weeks from baseline to Week 28 ]

3.  Primary:   Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)   [ Time Frame: Every 4 weeks from baseline to Week 28 ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medical Information
Organization: Vifor Pharma
phone: 41 58 851 8222
e-mail: medinfo@viforpharma.com


No publications provided


Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01464190     History of Changes
Other Study ID Numbers: PA-CL-05B
Study First Received: September 12, 2011
Results First Received: December 20, 2013
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices