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Trial record 27 of 380 for:    FERRIC CATION

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.
 
ClinicalTrials.gov Identifier: NCT00648167
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : October 9, 2014
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
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
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KRX-0502
Hide Arm/Group Description Ferric Citrate
Period Title: Overall Study
Started 55
Start Dose 4.5 g/Day 34
Start Dose 6 g/Day 21
Completed 48
Not Completed 7
Reason Not Completed
Adverse Event             6
unable to swallow tablets             1
Arm/Group Title KRX-0502
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
Intent-to-Treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
53.46  (11.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
23
  41.8%
Male
32
  58.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants
United States 50
Puerto Rico 5
1.Primary Outcome
Title The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate)
Hide Arm/Group Description:
Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 5.9  (1.4)
Day 28 5.4  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KRX-0502
Hide Arm/Group Description

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)

All-Cause Mortality
KRX-0502
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
KRX-0502
Affected / at Risk (%) # Events
Total   4/55 (7.27%)    
Cardiac disorders   
Worsened congestive heart failure   1/55 (1.82%)  1
Infections and infestations   
Liver infection   1/55 (1.82%)  1
Methicillin – susceptible staphylococcus aureus bacteremia   1/55 (1.82%)  1
Psychiatric disorders   
Suicide attempt   1/55 (1.82%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KRX-0502
Affected / at Risk (%) # Events
Total   46/55 (83.64%)    
Gastrointestinal disorders   
Stool color abnormality   34/55 (61.82%) 
Diarrhea   14/55 (25.45%) 
Constipation   11/55 (20.00%) 
Nausea   5/55 (9.09%) 
Vomiting   5/55 (9.09%) 
Bloating   4/55 (7.27%) 
Heartburn   4/55 (7.27%) 
Stomach pain or cramp   4/55 (7.27%) 
Increased appetite   3/55 (5.45%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Keryx Biopharmaceuticals Inc
Phone: 1-844-44-KERYX (1-844-445-3799
EMail: medicalinfo@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov 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