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Trial record 13 of 380 for:    FERRIC CATION

KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

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: NCT02268994
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : February 21, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anemia of Chronic Kidney Disease
Interventions Drug: ferric citrate
Drug: Placebo
Enrollment 234
Recruitment Details  
Pre-assignment Details 1 randomized subject was excluded because they did not receive study drug and were excluded from the safety population.
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Period Title: Overall Study
Started 117 116
Completed 86 81
Not Completed 31 35
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo Total
Hide Arm/Group Description

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Total of all reporting groups
Overall Number of Baseline Participants 117 116 233
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  41.0%
48
  41.4%
96
  41.2%
>=65 years
69
  59.0%
68
  58.6%
137
  58.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 116 participants 233 participants
65.6  (11.15) 65.2  (13.08) 65.4  (12.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
Female
76
  65.0%
71
  61.2%
147
  63.1%
Male
41
  35.0%
45
  38.8%
86
  36.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
Hispanic or Latino
29
  24.8%
24
  20.7%
53
  22.7%
Not Hispanic or Latino
88
  75.2%
92
  79.3%
180
  77.3%
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 117 participants 116 participants 233 participants
American Indian or Alaska Native
0
   0.0%
2
   1.7%
2
   0.9%
Asian
1
   0.9%
1
   0.9%
2
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
38
  32.5%
31
  26.7%
69
  29.6%
White
78
  66.7%
82
  70.7%
160
  68.7%
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%
1.Primary Outcome
Title Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
Hide Description Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Measure Type: Count of Participants
Unit of Measure: Participants
61
  52.1%
22
  19.1%
2.Secondary Outcome
Title Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
Hide Description The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
Time Frame Baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: g/dL
0.39  (0.054) -0.14  (0.056)
3.Secondary Outcome
Title Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
Hide Description The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
Time Frame Baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: % saturation
10.9  (0.65) -1.3  (0.67)
4.Secondary Outcome
Title Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
Hide Description The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
Time Frame Baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 gr of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
68.1  (3.99) -6.1  (4.10)
5.Secondary Outcome
Title Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
Hide Description Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Measure Type: Count of Participants
Unit of Measure: Participants
57
  48.7%
17
  14.8%
6.Secondary Outcome
Title Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
Hide Description The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
Time Frame Baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description:

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.28  (0.036) -0.14  (0.037)
Time Frame 16 Week Randomized Period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KRX-0502 (Ferric Citrate) Placebo
Hide Arm/Group Description

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron

Matching Placebo

Placebo: Matching placebo

All-Cause Mortality
KRX-0502 (Ferric Citrate) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/117 (1.71%)   0/116 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
KRX-0502 (Ferric Citrate) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/117 (11.97%)   13/116 (11.21%) 
Blood and lymphatic system disorders     
Iron Deficiency Anaemia   1/117 (0.85%)  0/116 (0.00%) 
Anaemia   0/117 (0.00%)  1/116 (0.86%) 
Cardiac disorders     
Cardiac Arrest   1/117 (0.85%)  0/116 (0.00%) 
Cardio-Respiratory Arrest   1/117 (0.85%)  0/116 (0.00%) 
Sick Sinus Syndrome   1/117 (0.85%)  0/116 (0.00%) 
Cardiac Failure Congestive   0/117 (0.00%)  2/116 (1.72%) 
Acute Myocardial Infarction   0/117 (0.00%)  1/116 (0.86%) 
Cardiac Failure Acute   0/117 (0.00%)  1/116 (0.86%) 
Gastrointestinal disorders     
Colitis Ischaemic   1/117 (0.85%)  0/116 (0.00%) 
Dysphagia   1/117 (0.85%)  0/116 (0.00%) 
Vomiting   0/117 (0.00%)  1/116 (0.86%) 
General disorders     
Necrosis   0/117 (0.00%)  1/116 (0.86%) 
Hepatobiliary disorders     
Cholangitis Acute   0/117 (0.00%)  1/116 (0.86%) 
Infections and infestations     
Pneumonia   2/117 (1.71%)  1/116 (0.86%) 
Clostridium Difficle Colitis   1/117 (0.85%)  1/116 (0.86%) 
Sepsis   1/117 (0.85%)  1/116 (0.86%) 
Abscess Limb   1/117 (0.85%)  0/116 (0.00%) 
Diverticulitis   1/117 (0.85%)  0/116 (0.00%) 
Septic Shock   1/117 (0.85%)  0/116 (0.00%) 
Urinary Tract Infection Fungal   1/117 (0.85%)  0/116 (0.00%) 
Celluitis   0/117 (0.00%)  2/116 (1.72%) 
Osteomyelitis   0/117 (0.00%)  1/116 (0.86%) 
Pyelonephritis Acute   0/117 (0.00%)  1/116 (0.86%) 
Injury, poisoning and procedural complications     
Abdominal Wound Dehiscence   1/117 (0.85%)  0/116 (0.00%) 
Procedural Haemorrhage   1/117 (0.85%)  0/116 (0.00%) 
Procedural Nausea   1/117 (0.85%)  0/116 (0.00%) 
Procedural Vomiting   1/117 (0.85%)  0/116 (0.00%) 
Investigations     
Blood Glucose Increased   1/117 (0.85%)  0/116 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia   2/117 (1.71%)  0/116 (0.00%) 
Diabetic Ketoacidosis   1/117 (0.85%)  0/116 (0.00%) 
Fluid Overload   1/117 (0.85%)  0/116 (0.00%) 
Hypoglycaemia   1/117 (0.85%)  0/116 (0.00%) 
Gout   0/117 (0.00%)  1/116 (0.86%) 
Hyperkalaemia   0/117 (0.00%)  1/116 (0.86%) 
Musculoskeletal and connective tissue disorders     
Back Pain   1/117 (0.85%)  0/116 (0.00%) 
Nervous system disorders     
Metabolic Encephalopathy   2/117 (1.71%)  0/116 (0.00%) 
Status Epilepticus   1/117 (0.85%)  0/116 (0.00%) 
Syncope   1/117 (0.85%)  0/116 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute   3/117 (2.56%)  2/116 (1.72%) 
Renal Failure Chronic   1/117 (0.85%)  2/116 (1.72%) 
Hydronephrosis   0/117 (0.00%)  1/116 (0.86%) 
Renal Impairment   0/117 (0.00%)  1/116 (0.86%) 
Urinary Retention   0/117 (0.00%)  1/116 (0.86%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure   3/117 (2.56%)  1/116 (0.86%) 
Chronic Respiratory Failure   1/117 (0.85%)  0/116 (0.00%) 
Pneumonia Aspiration   1/117 (0.85%)  0/116 (0.00%) 
Pulmonary Fibrosis   1/117 (0.85%)  0/116 (0.00%) 
Chronic Obstructive Pulmonary Disease   0/117 (0.00%)  1/116 (0.86%) 
Hypoxia   0/117 (0.00%)  1/116 (0.86%) 
Surgical and medical procedures     
Toe Amputation   1/117 (0.85%)  0/116 (0.00%) 
Vascular disorders     
Hypertension   1/117 (0.85%)  0/116 (0.00%) 
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 (Ferric Citrate) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   61/117 (52.14%)   41/116 (35.34%) 
Gastrointestinal disorders     
Diarrhoea   24/117 (20.51%)  19/116 (16.38%) 
Constipation   22/117 (18.80%)  15/116 (12.93%) 
Faeces Discoloured   17/117 (14.53%)  0/116 (0.00%) 
Nausea   13/117 (11.11%)  3/116 (2.59%) 
Abdominal Pain   7/117 (5.98%)  2/116 (1.72%) 
General disorders     
Fatigue   0/117 (0.00%)  6/116 (5.17%) 
Metabolism and nutrition disorders     
Hyperkalaemia   8/117 (6.84%)  4/116 (3.45%) 
Vascular disorders     
Hypertension   5/117 (4.27%)  6/116 (5.17%) 
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, Inc.
Phone: 1-844-44-KERYX (844-445-3799)
EMail: medicalinfo@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02268994     History of Changes
Other Study ID Numbers: KRX-0502-306
First Submitted: October 11, 2014
First Posted: October 20, 2014
Results First Submitted: November 30, 2017
Results First Posted: February 21, 2018
Last Update Posted: March 22, 2018