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Trial record 22 of 380 for:    FERRIC CATION

A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

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ClinicalTrials.gov Identifier: NCT01554982
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
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
Conditions End Stage Renal Disease
Kidney Failure
Renal Failure
Hyperphosphatemia
ESRD
Intervention Drug: ferric citrate
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ferric Citrate
Hide Arm/Group Description ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Period Title: Overall Study
Started 168
Received Drug 166
Completed 125
Not Completed 43
Arm/Group Title Ferric Citrate
Hide Arm/Group Description ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Baseline Participants 166
Hide Baseline Analysis Population Description
Note: two subjects randomized did not receive study drug, therefore not included in Safety Assessment Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants
<=18 years
0
   0.0%
Between 18 and 65 years
135
  81.3%
>=65 years
31
  18.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants
55.1  (11.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants
Female
63
  38.0%
Male
103
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants
Puerto Rico 2
United States 164
1.Primary Outcome
Title Safety Parameters
Hide Description Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency >5%
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Measure Type: Number
Unit of Measure: participants
Subjects with at least 1 TEAE 142
Subjects with at least 1 related TEAE 35
Subjects with at least 1 serious TEAE 75
Subjects with at least 1 related, serious TEAEa 0
Total # of deaths 10
2.Other Pre-specified Outcome
Title Serum Phosphorus- Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.7  (1.66)
3.Other Pre-specified Outcome
Title Serum Phosphorus- Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.2  (1.34)
4.Other Pre-specified Outcome
Title Ferritin- Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: ng/mL
709.7  (385.11)
5.Other Pre-specified Outcome
Title Ferritin- Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: ng/mL
821.0  (411.54)
6.Other Pre-specified Outcome
Title Transferrin Saturation (TSAT) - Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
32.4  (13.51)
7.Other Pre-specified Outcome
Title TSAT- Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
40.3  (19.12)
8.Other Pre-specified Outcome
Title Hemoglobin- Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: g/dL
11.1  (1.36)
9.Other Pre-specified Outcome
Title Hemoglobin- Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: g/dL
11.3  (1.38)
10.Other Pre-specified Outcome
Title IV Iron Use
Hide Description Percent of subjects with No IV iron intake from first dose of study drug to Week 48
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Citrate
Hide Arm/Group Description:
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Overall Number of Participants Analyzed 166
Measure Type: Number
Unit of Measure: percentage of participants
59.0
Time Frame 48 weeks
Adverse Event Reporting Description Treatment-emergent adverse events
 
Arm/Group Title Ferric Citrate
Hide Arm/Group Description ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
All-Cause Mortality
Ferric Citrate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Citrate
Affected / at Risk (%) # Events
Total   75/166 (45.18%)    
Blood and lymphatic system disorders   
Leukocytosis *  2/166 (1.20%)  2
Thrombocytopenia *  1/166 (0.60%)  1
Lymphadenopathy *  1/166 (0.60%)  1
Cardiac disorders   
Acute myocardial infarction *  3/166 (1.81%)  5
Angina pectoris *  4/166 (2.41%)  4
Atrial fibrillation *  3/166 (1.81%)  3
Bradycardia *  1/166 (0.60%)  1
Cardiac arrest *  6/166 (3.61%)  6
Cardiac failure congestive *  4/166 (2.41%)  4
Ischaemic cardiomyopathy *  1/166 (0.60%)  1
Myocardial infarction *  1/166 (0.60%)  1
Pericardial effusion *  1/166 (0.60%)  1
Pleuropericarditis *  1/166 (0.60%)  1
Tachycardia *  1/166 (0.60%)  1
Ventricular fibrillation *  1/166 (0.60%)  1
Ventricular tachycardia *  1/166 (0.60%)  1
Dyspnoea *  4/166 (2.41%)  4
Ear and labyrinth disorders   
Vertigo positional *  1/166 (0.60%)  1
Endocrine disorders   
Hyperparathyroidism *  2/166 (1.20%)  2
Gastrointestinal disorders   
Diarrhoea *  1/166 (0.60%)  1
Diverticulitis intestinal haemorrhagic *  1/166 (0.60%)  1
Diverticulum intestinal haemorrhagic *  1/166 (0.60%)  1
Gastrointestinal haemorrhage *  2/166 (1.20%)  2
Haematemesis *  1/166 (0.60%)  1
Ileus paralytic *  1/166 (0.60%)  1
Lower gastrointestinal haemorrhage *  1/166 (0.60%)  1
Peritonitis *  2/166 (1.20%)  2
Rectal haemorrhage *  1/166 (0.60%)  1
Retroperitoneal haematoma *  2/166 (1.20%)  2
Umbilical hernia, obstructive *  1/166 (0.60%)  1
Vomiting *  1/166 (0.60%)  1
General disorders   
Chest pain *  2/166 (1.20%)  2
Death *  2/166 (1.20%)  2
Necrosis *  1/166 (0.60%)  1
Non-cardiac chest pain *  3/166 (1.81%)  3
Pyrexia *  5/166 (3.01%)  5
Sudden death *  1/166 (0.60%)  1
Infections and infestations   
Abscess limb *  1/166 (0.60%)  1
Arteriovenous graft site infection *  2/166 (1.20%)  2
Bacteraemia *  1/166 (0.60%)  1
Bacterial sepsis *  1/166 (0.60%)  1
Cellulitis *  2/166 (1.20%)  2
Cellulitis streptococcal *  1/166 (0.60%)  1
Device related infection *  1/166 (0.60%)  1
Furuncle *  1/166 (0.60%)  1
Gangrene *  1/166 (0.60%)  1
Incision site abscess *  1/166 (0.60%)  1
Infected skin ulcer *  1/166 (0.60%)  2
Klebsiella bacteraemia *  1/166 (0.60%)  1
Liver abscess *  1/166 (0.60%)  1
Localised infection *  1/166 (0.60%)  1
Meningitis viral *  1/166 (0.60%)  1
Osteomyelitis *  1/166 (0.60%)  1
Perirectal abscess *  1/166 (0.60%)  1
Peritoneal abscess *  1/166 (0.60%)  1
Pneumonia *  10/166 (6.02%)  10
Postoperative wound infection *  2/166 (1.20%)  2
Sepsis *  8/166 (4.82%)  8
Septic shock *  1/166 (0.60%)  1
Staphylococcal bacteraemia *  1/166 (0.60%)  1
Staphylococcal infection *  1/166 (0.60%)  2
Abdominal Abscess *  1/166 (0.60%)  1
Pelvic abscess *  1/166 (0.60%)  1
Injury, poisoning and procedural complications   
Arteriovenous fistula site complication *  1/166 (0.60%)  1
Arteriovenous fistula thrombosis *  1/166 (0.60%)  1
Humerus fracture *  1/166 (0.60%)  1
Joint dislocation *  1/166 (0.60%)  1
Postoperative wound complication *  1/166 (0.60%)  1
Subdural haematoma *  1/166 (0.60%)  2
Vascular graft complication *  2/166 (1.20%)  2
Vascular graft thrombosis *  2/166 (1.20%)  2
Wound dehiscence *  2/166 (1.20%)  3
Wound haemorrhage *  1/166 (0.60%)  1
Complications of transplant surgery *  1/166 (0.60%)  1
Investigations   
Oxygen saturation decreased *  1/166 (0.60%)  1
Aspiration pleural cavity *  1/166 (0.60%)  1
Metabolism and nutrition disorders   
Diabetic foot *  1/166 (0.60%)  1
Fluid overload *  5/166 (3.01%)  5
Hyperkalaemia *  3/166 (1.81%)  3
Hypocalcaemia *  1/166 (0.60%)  1
Lactic acidosis *  1/166 (0.60%)  1
Metabolic encephalopathy *  1/166 (0.60%)  1
Hypoglycemia *  2/166 (1.20%)  2
Dehydration *  1/166 (0.60%)  1
Musculoskeletal and connective tissue disorders   
Arthritis *  1/166 (0.60%)  1
Back pain *  2/166 (1.20%)  2
Lumbar spinal stenosis *  1/166 (0.60%)  1
Musculoskeletal chest pain *  1/166 (0.60%)  1
Neuropathic arthropathy *  1/166 (0.60%)  1
Osteoarthritis *  2/166 (1.20%)  2
Spinal osteoarthritis *  1/166 (0.60%)  1
Systemic lupus erythematosus *  1/166 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant *  1/166 (0.60%)  1
Nervous system disorders   
Syncope *  4/166 (2.41%)  4
Unresponsive to stimuli *  1/166 (0.60%)  1
Cerebral thrombosis *  1/166 (0.60%)  1
Transient ischaemic attack *  1/166 (0.60%)  1
Paraparesis *  1/166 (0.60%)  1
Dizziness *  1/166 (0.60%)  1
Psychiatric disorders   
Disorientation *  1/166 (0.60%)  1
Mental disorder *  3/166 (1.81%)  3
Confusional state *  1/166 (0.60%)  1
Renal and urinary disorders   
Azotaemia *  1/166 (0.60%)  1
Reproductive system and breast disorders   
Postmenopausal haemorrhage *  1/166 (0.60%)  1
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema *  2/166 (1.20%)  2
Acute respiratory distress syndrome *  1/166 (0.60%)  1
Acute respiratory failure *  1/166 (0.60%)  1
Asthma *  1/166 (0.60%)  1
Dyspnoea *  1/166 (0.60%)  2
Pleural effusion *  3/166 (1.81%)  4
Pneumonia aspiration *  1/166 (0.60%)  1
Pulmonary embolism *  1/166 (0.60%)  1
Pulmonary oedema *  3/166 (1.81%)  3
Respiratory distress *  1/166 (0.60%)  2
Respiratory failure *  2/166 (1.20%)  2
Skin and subcutaneous tissue disorders   
Angioedema *  1/166 (0.60%)  1
Surgical and medical procedures   
Cardiac pacemaker insertion *  1/166 (0.60%)  1
Catheter placement *  2/166 (1.20%)  2
Leg amputation *  2/166 (1.20%)  2
Parathyroidectomy *  1/166 (0.60%)  1
Peritoneal dialysis *  1/166 (0.60%)  1
Renal transplant *  10/166 (6.02%)  10
Spinal fusion surgery *  1/166 (0.60%)  2
Vascular disorders   
Aneurysm *  1/166 (0.60%)  1
Brachiocephalic vein stenosis *  1/166 (0.60%)  1
Deep vein thrombosis *  2/166 (1.20%)  2
Hypertension *  2/166 (1.20%)  2
Hypertensive crisis *  2/166 (1.20%)  2
Hypertensive emergency *  1/166 (0.60%)  1
Hypotension *  5/166 (3.01%)  6
Peripheral vascular disorder *  1/166 (0.60%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferric Citrate
Affected / at Risk (%) # Events
Total   142/166 (85.54%)    
Cardiac disorders   
Dyspnoea *  13/166 (7.83%)  16
Gastrointestinal disorders   
Constipation *  9/166 (5.42%)  11
Diarrhoea *  26/166 (15.66%)  29
Faeces discoloured *  14/166 (8.43%)  14
Nausea *  17/166 (10.24%)  20
Oedema peripheral *  10/166 (6.02%)  15
Vomiting *  16/166 (9.64%)  23
General disorders   
Pyrexia *  9/166 (5.42%)  9
Infections and infestations   
Nasopharyngitis *  10/166 (6.02%)  11
Injury, poisoning and procedural complications   
Arteriovenous fistula site complication *  12/166 (7.23%)  17
Fall *  9/166 (5.42%)  14
Vascular graft complication *  9/166 (5.42%)  10
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain *  10/166 (6.02%)  16
Pain in extremity *  11/166 (6.63%)  28
Nervous system disorders   
Dizziness *  9/166 (5.42%)  13
Headache *  14/166 (8.43%)  23
Respiratory, thoracic and mediastinal disorders   
Cough *  11/166 (6.63%)  14
Vascular disorders   
Hypertension *  9/166 (5.42%)  11
Hypotension *  10/166 (6.02%)  66
*
Indicates events were collected by non-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: Lisa Loram
Organization: Keryx
Phone: 919-434-6195
EMail: lisa.loram@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01554982     History of Changes
Other Study ID Numbers: KRX-0502-307
First Submitted: March 12, 2012
First Posted: March 15, 2012
Results First Submitted: September 24, 2015
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016