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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00648167
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : October 9, 2014
Last Update Posted : April 4, 2017
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hyperphosphatemia
End-stage Renal Disease
Intervention: Drug: ferric citrate

  Participant Flow

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
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Reporting Groups
KRX-0502 Ferric Citrate

Participant Flow:   Overall Study
Start Dose 4.5 g/Day   34 
Start Dose 6 g/Day   21 
Adverse Event                6 
unable to swallow tablets                1 

  Baseline Characteristics

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.

Reporting Groups
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
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 53.46  (11.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      23  41.8% 
Male      32  58.2% 
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

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

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

Responsible Party: Keryx Biopharmaceuticals Identifier: NCT00648167     History of Changes
Other Study ID Numbers: KRX-0502-201
First Submitted: March 27, 2008
First Posted: April 1, 2008
Results First Submitted: October 4, 2014
Results First Posted: October 9, 2014
Last Update Posted: April 4, 2017