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Trial record 38 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT01736397
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

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
Enrollment 149
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 75 74
Completed 61 50
Not Completed 14 24
Reason Not Completed
Lack of Efficacy             1             11
Withdrawal by Subject             6             5
Lost to Follow-up             0             1
Adverse Event             6             3
Not stated             1             4
Arm/Group Title Ferric Citrate Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 75 73 148
Hide Baseline Analysis Population Description
One subject on placebo was randomized but never received drug and so was excluded from the safety population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 148 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 73 participants 148 participants
65.8  (12.15) 64.5  (13.55) 65.1  (12.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 148 participants
Female
51
  68.0%
45
  61.6%
96
  64.9%
Male
24
  32.0%
28
  38.4%
52
  35.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 148 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 148 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 75 participants 73 participants 148 participants
75
 100.0%
73
 100.0%
148
 100.0%
Chronic kidney disease (CKD), stage at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 148 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]
Measure Description:

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

1.Primary Outcome
Title Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
Hide Description The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were based on Intent-to-Treat (ITT) population, which consisted of all randomized subjects who had a baseline laboratory value, had taken at least 1 dose of study drug, & had at least 1 post-baseline laboratory value. ANCOVA with Last observation carried forward (LOCF) methodology was used.
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 72 69
Mean (Standard Deviation)
Unit of Measure: % saturation
Baseline 21.6  (7.44) 21.0  (8.26)
Week 12 31.7  (14.19) 20.0  (7.55)
2.Primary Outcome
Title Change in Serum Phosphorus Levels From Baseline to End of Treatment
Hide Description The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 72 69
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 4.5  (0.61) 4.7  (0.60)
12 weeks 3.9  (0.58) 4.4  (0.75)
3.Secondary Outcome
Title Change in Ferritin Levels From Baseline to End of Treatment
Hide Description The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 72 69
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 115.8  (83.11) 110.0  (80.88)
Week 12 189.4  (122.16) 105.6  (93.87)
4.Secondary Outcome
Title Change in Hemoglobin Levels From Baseline to End of Treatment
Hide Description The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 72 69
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 10.5  (0.81) 10.6  (1.07)
Week 12 11.0  (1.03) 10.4  (1.14)
Time Frame 12 weeks
Adverse Event Reporting Description One subject on placebo was randomized but never received drug and so was excluded from the safety population
 
Arm/Group Title Ferric Citrate Placebo
Hide Arm/Group Description

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 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

All-Cause Mortality
Ferric Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   2/73 (2.74%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/75 (8.00%)   9/73 (12.33%) 
Cardiac disorders     
Atrial Fibrillation  1  2/75 (2.67%)  0/73 (0.00%) 
Acute Coronary Syndrome  1  1/75 (1.33%)  0/73 (0.00%) 
Congestive Cardiac Failure  1  1/75 (1.33%)  1/73 (1.37%) 
Cardiac Arrest  1  0/75 (0.00%)  1/73 (1.37%) 
General disorders     
Chest Pain  1  0/75 (0.00%)  2/73 (2.74%) 
Infections and infestations     
Pneumonia  1  1/75 (1.33%)  0/73 (0.00%) 
Pyelonephritis  1  0/75 (0.00%)  1/73 (1.37%) 
Injury, poisoning and procedural complications     
Femoral Neck Fracture  1  0/75 (0.00%)  1/73 (1.37%) 
Investigations     
Haemoglobin decreased  1  0/75 (0.00%)  1/73 (1.37%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/75 (0.00%)  1/73 (1.37%) 
Hypokalaemia  1  0/75 (0.00%)  1/73 (1.37%) 
Hyponatraemia  1  0/75 (0.00%)  1/73 (1.37%) 
Renal and urinary disorders     
Renal Failure Acute  1  1/75 (1.33%)  1/73 (1.37%) 
Renal Failure Chronic  1  0/75 (0.00%)  1/73 (1.37%) 
Respiratory, thoracic and mediastinal disorders     
COPD  1  1/75 (1.33%)  1/73 (1.37%) 
Vascular disorders     
Accelerated Hypertension  1  0/75 (0.00%)  1/73 (1.37%) 
1
Term from vocabulary, MedDRA (13.0)
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 2%
Ferric Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   52/75 (69.33%)   43/73 (58.90%) 
Blood and lymphatic system disorders     
Anaemia  1  2/75 (2.67%)  1/73 (1.37%) 
Cardiac disorders     
Atrial Fibrillation  1  2/75 (2.67%)  0/73 (0.00%) 
Gastrointestinal disorders     
Faeces Discolored  1  24/75 (32.00%)  0/73 (0.00%) 
Diarrhoea  1  15/75 (20.00%)  4/73 (5.48%) 
Constipation  1  14/75 (18.67%)  4/73 (5.48%) 
Nausea  1  5/75 (6.67%)  5/73 (6.85%) 
Vomiting  1  4/75 (5.33%)  4/73 (5.48%) 
Abdominal Discomfort  1  2/75 (2.67%)  1/73 (1.37%) 
Abdominal Pain  1  2/75 (2.67%)  1/73 (1.37%) 
Abdominal Pain Upper  1  2/75 (2.67%)  2/73 (2.74%) 
Dyspepsia  1  2/75 (2.67%)  0/73 (0.00%) 
Haemorrhoids  1  2/75 (2.67%)  0/73 (0.00%) 
General disorders     
Fatigue  1  2/75 (2.67%)  1/73 (1.37%) 
Oedema  1  2/75 (2.67%)  1/73 (1.37%) 
Oedema Peripheral  1  3/75 (4.00%)  1/73 (1.37%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  4/75 (5.33%)  0/73 (0.00%) 
Urinary Tract Infection  1  2/75 (2.67%)  4/73 (5.48%) 
Injury, poisoning and procedural complications     
Foot Fracture  1  2/75 (2.67%)  1/73 (1.37%) 
Metabolism and nutrition disorders     
Gout  1  2/75 (2.67%)  0/73 (0.00%) 
Hyperglycaemia  1  2/75 (2.67%)  1/73 (1.37%) 
Hyperkalaemia  1  2/75 (2.67%)  1/73 (1.37%) 
Hypoglycaemia  1  2/75 (2.67%)  1/73 (1.37%) 
Nervous system disorders     
Dizziness  1  0/75 (0.00%)  3/73 (4.11%) 
Dysgeusia  1  0/75 (0.00%)  2/73 (2.74%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/75 (1.33%)  3/73 (4.11%) 
Skin and subcutaneous tissue disorders     
Pruritis  1  1/75 (1.33%)  3/73 (4.11%) 
Rash  1  0/75 (0.00%)  2/73 (2.74%) 
Vascular disorders     
Hypertension  1  2/75 (2.67%)  1/73 (1.37%) 
1
Term from vocabulary, MedDRA (13.0)
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
Layout table for Results Point of Contact information
Name/Title: Keryx Medical Information
Organization: Keryx Biopharmaceuticals
Phone: 1-844-44-KERYX (844-445-3799)
EMail: medicalinfo@keryx.com
Layout table for additonal information
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