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Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736397
First Posted: November 29, 2012
Last Update Posted: October 20, 2017
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.
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Iron Deficiency
Iron Deficiency Anemia
Interventions: Drug: Ferric Citrate
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Ferric Citrate

Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.

Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit.

Placebo

Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.

Placebo


Participant Flow:   Overall Study
    Ferric Citrate   Placebo
STARTED   75   74 
COMPLETED   61   50 
NOT COMPLETED   14   24 
Lack of Efficacy                1                11 
Withdrawal by Subject                6                5 
Lost to Follow-up                0                1 
Adverse Event                6                3 
Not stated                1                4 



  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.
One subject on placebo was randomized but never received drug and so was excluded from the safety population

Reporting Groups
  Description
Ferric Citrate

Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit.

Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit.

Placebo

Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.

Placebo

Total Total of all reporting groups

Baseline Measures
   Ferric Citrate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   73   148 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31  41.3%      34  46.6%      65  43.9% 
>=65 years      44  58.7%      39  53.4%      83  56.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.8  (12.15)   64.5  (13.55)   65.1  (12.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      51  68.0%      45  61.6%      96  64.9% 
Male      24  32.0%      28  38.4%      52  35.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      15  20.0%      21  28.8%      36  24.3% 
Not Hispanic or Latino      60  80.0%      52  71.2%      112  75.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   1.4%      1   0.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      16  21.3%      16  21.9%      32  21.6% 
White      59  78.7%      56  76.7%      115  77.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   75   73   148 
Chronic kidney disease (CKD), stage at baseline [1] 
[Units: Participants]
Count of Participants
     
Stage III      14  18.7%      16  21.9%      30  20.3% 
Stage IV      39  52.0%      39  53.4%      78  52.7% 
Stage V      21  28.0%      17  23.3%      38  25.7% 
Other      1   1.3%      1   1.4%      2   1.4% 
[1]

The stage of CKD disease was measured by the estimated glomerular filtration rate (eGFR), where CKD Stage III relates to better kidney function compare to CKD Stage V, that has worse kidney function.

Stage III: eGFR 30-59 mL/min/1.73 m2 Stage IV eGFR 15-29 mL/min/1.73 m2 Stage V eGFR<15 mL/min/1.73 m2 Other eGFR >=60 mL/min/1.73 m2



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment   [ Time Frame: 12 Weeks ]

2.  Primary:   Change in Serum Phosphorus Levels From Baseline to End of Treatment   [ Time Frame: 12 Weeks ]

3.  Secondary:   Change in Ferritin Levels From Baseline to End of Treatment   [ Time Frame: 12 Weeks ]

4.  Secondary:   Change in Hemoglobin Levels From Baseline to End of Treatment   [ Time Frame: 12 Weeks ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01736397     History of Changes
Other Study ID Numbers: KRX-0502-204
First Submitted: November 16, 2012
First Posted: November 29, 2012
Results First Submitted: August 17, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017