Trial Outcomes & Findings for A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis (NCT NCT01554982)
NCT ID: NCT01554982
Last Updated: 2016-07-13
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
48 Weeks
Results posted on
2016-07-13
Participant Flow
Participant milestones
| Measure |
Ferric Citrate
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Overall Study
STARTED
|
168
|
|
Overall Study
Received Drug
|
166
|
|
Overall Study
COMPLETED
|
125
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Baseline characteristics by cohort
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 WeeksPopulation: Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency \>5%
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).
Outcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Safety Parameters
Subjects with at least 1 TEAE
|
142 participants
|
|
Safety Parameters
Subjects with at least 1 related TEAE
|
35 participants
|
|
Safety Parameters
Subjects with at least 1 serious TEAE
|
75 participants
|
|
Safety Parameters
Subjects with at least 1 related, serious TEAEa
|
0 participants
|
|
Safety Parameters
Total # of deaths
|
10 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Serum Phosphorus- Baseline
|
5.7 mg/dL
Standard Deviation 1.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Ferric Citrate
n=126 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Serum Phosphorus- Week 48
|
5.2 mg/dL
Standard Deviation 1.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Ferritin- Baseline
|
709.7 ng/mL
Standard Deviation 385.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Ferric Citrate
n=126 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Ferritin- Week 48
|
821.0 ng/mL
Standard Deviation 411.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Transferrin Saturation (TSAT) - Baseline
|
32.4 percentage of saturation
Standard Deviation 13.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Ferric Citrate
n=126 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
TSAT- Week 48
|
40.3 percentage of saturation
Standard Deviation 19.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Hemoglobin- Baseline
|
11.1 g/dL
Standard Deviation 1.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Ferric Citrate
n=126 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Hemoglobin- Week 48
|
11.3 g/dL
Standard Deviation 1.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksPercent of subjects with No IV iron intake from first dose of study drug to Week 48
Outcome measures
| Measure |
Ferric Citrate
n=166 Participants
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
IV Iron Use
|
59.0 percentage of participants
|
Adverse Events
Ferric Citrate
Serious events: 75 serious events
Other events: 142 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Citrate
n=166 participants at risk
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
3/166 • Number of events 5 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Angina pectoris
|
2.4%
4/166 • Number of events 4 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
3/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Bradycardia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Cardiac arrest
|
3.6%
6/166 • Number of events 6 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Cardiac failure congestive
|
2.4%
4/166 • Number of events 4 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Pericardial effusion
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Pleuropericarditis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Ventricular fibrillation
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Ventricular tachycardia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Dyspnoea
|
2.4%
4/166 • Number of events 4 • 48 weeks
Treatment-emergent adverse events
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Endocrine disorders
Hyperparathyroidism
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Haematemesis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Peritonitis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Chest pain
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Death
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Necrosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Non-cardiac chest pain
|
1.8%
3/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Pyrexia
|
3.0%
5/166 • Number of events 5 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Sudden death
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Abscess limb
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Arteriovenous graft site infection
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Bacteraemia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Bacterial sepsis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Cellulitis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Cellulitis streptococcal
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Device related infection
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Furuncle
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Gangrene
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Incision site abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Infected skin ulcer
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Liver abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Localised infection
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Meningitis viral
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Osteomyelitis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Perirectal abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Peritoneal abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Pneumonia
|
6.0%
10/166 • Number of events 10 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Sepsis
|
4.8%
8/166 • Number of events 8 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Septic shock
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Staphylococcal infection
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.2%
2/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Investigations
Oxygen saturation decreased
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Investigations
Aspiration pleural cavity
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.0%
5/166 • Number of events 5 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.8%
3/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Metabolic encephalopathy
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Syncope
|
2.4%
4/166 • Number of events 4 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Cerebral thrombosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Paraparesis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Disorientation
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Mental disorder
|
1.8%
3/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
Psychiatric disorders
Confusional state
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
3/166 • Number of events 4 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
3/166 • Number of events 3 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Catheter placement
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Leg amputation
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Peritoneal dialysis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Renal transplant
|
6.0%
10/166 • Number of events 10 • 48 weeks
Treatment-emergent adverse events
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.60%
1/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Aneurysm
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypertension
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypertensive crisis
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypertensive emergency
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypotension
|
3.0%
5/166 • Number of events 6 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Peripheral vascular disorder
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
2/166 • Number of events 2 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Abdominal Abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Pelvic abscess
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Dizziness
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
|
Renal and urinary disorders
Azotaemia
|
0.60%
1/166 • Number of events 1 • 48 weeks
Treatment-emergent adverse events
|
Other adverse events
| Measure |
Ferric Citrate
n=166 participants at risk
ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
|
|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
7.2%
12/166 • Number of events 17 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Constipation
|
5.4%
9/166 • Number of events 11 • 48 weeks
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
11/166 • Number of events 14 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
26/166 • Number of events 29 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Dizziness
|
5.4%
9/166 • Number of events 13 • 48 weeks
Treatment-emergent adverse events
|
|
Cardiac disorders
Dyspnoea
|
7.8%
13/166 • Number of events 16 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Faeces discoloured
|
8.4%
14/166 • Number of events 14 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
9/166 • Number of events 14 • 48 weeks
Treatment-emergent adverse events
|
|
Nervous system disorders
Headache
|
8.4%
14/166 • Number of events 23 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypertension
|
5.4%
9/166 • Number of events 11 • 48 weeks
Treatment-emergent adverse events
|
|
Vascular disorders
Hypotension
|
6.0%
10/166 • Number of events 66 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
10/166 • Number of events 16 • 48 weeks
Treatment-emergent adverse events
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
10/166 • Number of events 11 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Nausea
|
10.2%
17/166 • Number of events 20 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Oedema peripheral
|
6.0%
10/166 • Number of events 15 • 48 weeks
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
11/166 • Number of events 28 • 48 weeks
Treatment-emergent adverse events
|
|
General disorders
Pyrexia
|
5.4%
9/166 • Number of events 9 • 48 weeks
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
5.4%
9/166 • Number of events 10 • 48 weeks
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
16/166 • Number of events 23 • 48 weeks
Treatment-emergent adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place