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Trial record 15 of 380 for:    FERRIC CATION

Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

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: NCT00967993
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : November 18, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type Observational
Study Design Time Perspective: Retrospective
Conditions Hyperphosphatemia
End-stage Renal Disease
Renal Failure Chronic Requiring Hemodialysis
Intervention Drug: ferric citrate
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KRX-0502
Hide Arm/Group Description All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
Period Title: Overall Study
Started 22
Completed 18
Not Completed 4
Arm/Group Title KRX-0502
Hide Arm/Group Description All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
55  (0.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  72.7%
>=65 years
6
  27.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
7
  31.8%
Male
15
  68.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 22 participants
22
1.Primary Outcome
Title The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate)
Hide Arm/Group Description:
Single arm clinical trial of KRX-0502 (ferric citrate)
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.53  (1.22)
2.Secondary Outcome
Title The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.
Hide Description [Not Specified]
Time Frame 6 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KRX-0502 (Ferric Citrate)
Hide Arm/Group Description Single arm clinical trial of KRX-0502 (ferric citrate)
All-Cause Mortality
KRX-0502 (Ferric Citrate)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
KRX-0502 (Ferric Citrate)
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KRX-0502 (Ferric Citrate)
Affected / at Risk (%) # Events
Total   8/22 (36.36%)    
Gastrointestinal disorders   
Abdominal Pain   2/22 (9.09%)  3
Diarrhea   2/22 (9.09%)  3
Dyspepsia   3/22 (13.64%)  3
Exacerbation of Constipation   1/22 (4.55%)  1
Loose Stool Intermittent   1/22 (4.55%)  1
Nausea   1/22 (4.55%)  1
Odor of ferric citrate   1/22 (4.55%)  1
General disorders   
Clotted A-V Fistula Recurrent   1/22 (4.55%)  1
Exertion Fatigue   1/22 (4.55%)  1
Fatigue   1/22 (4.55%)  1
Strange Feeling in Head   1/22 (4.55%)  2
Hepatobiliary disorders   
Liver Enzyme Elevation   1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Knee Pain   1/22 (4.55%)  1
Nervous system disorders   
Hand Dysaesthsia   1/22 (4.55%)  1
Renal and urinary disorders   
Decrease in Urea Reduction Rate   1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/22 (4.55%)  1
Skin and subcutaneous tissue disorders   
Itching   2/22 (9.09%)  2
Rash Diffuse   1/22 (4.55%)  1
Vascular disorders   
Low BP Dizziness Weakness   1/22 (4.55%)  1
Syncope   1/22 (4.55%)  1
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 (1-844-445-379
EMail: medicalinfo@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00967993     History of Changes
Other Study ID Numbers: KRX-0502-202
First Submitted: August 27, 2009
First Posted: August 28, 2009
Results First Submitted: October 4, 2014
Results First Posted: November 18, 2014
Last Update Posted: December 5, 2014