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Trial record 67 of 380 for:    FERRIC CATION

A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

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: NCT02128074
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia of Chronic Kidney Disease
Intervention Drug: KRX-0502
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KRX-0502
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KRX-0502 (ferric citrate)

KRX-0502: 1g tablets of KRX-0502

Period Title: Overall Study
Started 32
Completed 26
Not Completed 6
Arm/Group Title KRX-0502
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KRX-0502 (ferric citrate)

KRX-0502: 1g tablets of KRX-0502

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  25.0%
>=65 years
24
  75.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
69.3  (12.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
15
  46.9%
Male
17
  53.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
32
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
31
  96.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.1%
1.Primary Outcome
Title Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
Hide Description [Not Specified]
Time Frame 8 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502
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KRX-0502 (ferric citrate)

KRX-0502: 1g tablets of KRX-0502

Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 10.8  (0.77)
Week 8 11.1  (0.81)
Time Frame 8 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KRX-0502
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KRX-0502 (ferric citrate)

KRX-0502: 1g tablets of KRX-0502

All-Cause Mortality
KRX-0502
Affected / at Risk (%)
Total   1/32 (3.13%) 
Show Serious Adverse Events Hide Serious Adverse Events
KRX-0502
Affected / at Risk (%)
Total   2/32 (6.25%) 
Cardiac disorders   
Cardiac Failure Chronic   1/32 (3.13%) 
General disorders   
Rib Fracture   1/32 (3.13%) 
Urinary Tract Infection   1/32 (3.13%) 
General Physical Health Deterioration   1/32 (3.13%) 
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 (%)
Total   25/32 (78.13%) 
Gastrointestinal disorders   
Diarrhoea   9/32 (28.13%) 
Faeces Discoloured   8/32 (25.00%) 
Abdominal Pain   6/32 (18.75%) 
Constipation   3/32 (9.38%) 
Abdominal Discomfort   2/32 (6.25%) 
Vomiting   2/32 (6.25%) 
Investigations   
Weight Decrease   2/32 (6.25%) 
Metabolism and nutrition disorders   
Hyperkalaemia   2/32 (6.25%) 
Hypocalcaemia   2/32 (6.25%) 
Nervous system disorders   
Dizziness   2/32 (6.25%) 
Vascular disorders   
Hypotension   2/32 (6.25%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
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Name/Title: Keryx Medical Information
Organization: Keryx Biopharmaceuticals, Inc
Phone: 1-844-44-KERYX (844-445-3799)
EMail: medicalinfo@keryx.com
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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02128074     History of Changes
Other Study ID Numbers: KRX-0502-207
First Submitted: April 28, 2014
First Posted: May 1, 2014
Results First Submitted: November 30, 2017
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018