A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

This study has been completed.
Sponsor:
Collaborator:
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648167
First received: March 27, 2008
Last updated: October 10, 2014
Last verified: October 2014
Results First Received: October 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hyperphosphatemia
End-stage Renal Disease
Intervention: Drug: ferric citrate

  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
KRX-0502

Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)

Intent-to-Treat (ITT)


Participant Flow:   Overall Study
    KRX-0502  
STARTED     55  
COMPLETED     48  
NOT COMPLETED     7  



  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.
Intent-to-Treat

Reporting Groups
  Description
KRX-0502 Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)

Baseline Measures
    KRX-0502  
Number of Participants  
[units: participants]
  55  
Age  
[units: years]
Mean ± Standard Deviation
  53.46  ± 11.48  
Gender  
[units: participants]
 
Female     23  
Male     32  
Region of Enrollment  
[units: participants]
 
United States     50  
Puerto Rico     5  



  Outcome Measures

1.  Primary:   The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)   [ Time Frame: 28 days ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Medical Information
Organization: Keryx Biopharmaceuticals Inc
phone: 1-844-44-KERYX (1-844-445-3799
e-mail: medicalinfo@keryx.com


No publications provided


Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00648167     History of Changes
Other Study ID Numbers: KRX-0502-201
Study First Received: March 27, 2008
Results First Received: October 4, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration