Trial Outcomes & Findings for Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months (NCT NCT02163499)
NCT ID: NCT02163499
Last Updated: 2018-06-27
Results Overview
Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
72 Hours
Results posted on
2018-06-27
Participant Flow
Participants took part in the study at 56 sites in the Unites States, Australia, South Africa, Germany, the United Kingdom and the Netherlands from 23 June 2014 to 04 November 2016
Participant milestones
| Measure |
Subject Disposition
All Screened Subjects
|
|---|---|
|
Acute Phase: ZS 10 g TID
STARTED
|
751
|
|
Acute Phase: ZS 10 g TID
COMPLETED
|
746
|
|
Acute Phase: ZS 10 g TID
NOT COMPLETED
|
5
|
|
Extended Dosing Phase: ZS
STARTED
|
746
|
|
Extended Dosing Phase: ZS
COMPLETED
|
466
|
|
Extended Dosing Phase: ZS
NOT COMPLETED
|
280
|
Reasons for withdrawal
| Measure |
Subject Disposition
All Screened Subjects
|
|---|---|
|
Acute Phase: ZS 10 g TID
Participant's Compliance
|
1
|
|
Acute Phase: ZS 10 g TID
Hypo- or Hyperkalemia
|
1
|
|
Acute Phase: ZS 10 g TID
Protocol Violation
|
1
|
|
Acute Phase: ZS 10 g TID
Physician Decision
|
1
|
|
Acute Phase: ZS 10 g TID
Withdrawal by Subject
|
1
|
|
Extended Dosing Phase: ZS
Adverse Event
|
51
|
|
Extended Dosing Phase: ZS
Expected Progression of CKD
|
40
|
|
Extended Dosing Phase: ZS
Hypokalemia
|
9
|
|
Extended Dosing Phase: ZS
Sponsor's Decision
|
5
|
|
Extended Dosing Phase: ZS
Met ECG Withdrawal Criteria
|
7
|
|
Extended Dosing Phase: ZS
Withdrawal by Subject
|
81
|
|
Extended Dosing Phase: ZS
Physician Decision
|
8
|
|
Extended Dosing Phase: ZS
Lost to Follow-up
|
31
|
|
Extended Dosing Phase: ZS
Protocol Violation
|
2
|
|
Extended Dosing Phase: ZS
Death
|
8
|
|
Extended Dosing Phase: ZS
Subject Compliance
|
17
|
|
Extended Dosing Phase: ZS
Hyperkalemia
|
5
|
|
Extended Dosing Phase: ZS
Various reasons
|
16
|
Baseline Characteristics
Acute Phase Safety Population
Baseline characteristics by cohort
| Measure |
Acute Phase: ZS
n=751 Participants
|
|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=5 Participants • Acute Phase Safety Population
|
|
Sex: Female, Male
Male
|
448 Participants
n=5 Participants • Acute Phase Safety Population
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
624 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
|
Use of RAAS inhibitor medication
|
527 Participants
n=5 Participants • Acute Phase - Safety Population
|
|
Co-morbidities at baseline
Diabetes mellitus
|
471 Participants
n=5 Participants • Acute Phase - Safety Population
|
|
Co-morbidities at baseline
Chronic kidney disease
|
513 Participants
n=5 Participants • Acute Phase - Safety Population
|
|
Co-morbidities at baseline
Heart Failure
|
285 Participants
n=5 Participants • Acute Phase - Safety Population
|
|
Baseline eGFR
<15
|
46 Participants
n=5 Participants
|
|
Baseline eGFR
15-<30
|
243 Participants
n=5 Participants
|
|
Baseline eGFR
30-<60
|
263 Participants
n=5 Participants
|
|
Baseline eGFR
≥60
|
190 Participants
n=5 Participants
|
|
Baseline eGFR
Missing
|
9 Participants
n=5 Participants
|
|
Acute Phase baseline Serum Potassium
<5.5 mmol/L
|
287 Participants
n=5 Participants • Acute Phase baseline S-K is the mean of 2 different pretreatment S-K values, recorded 60 (± 15 minutes) apart on Acute Phase Day 1.
|
|
Acute Phase baseline Serum Potassium
5.5<6.0 mmol/L
|
338 Participants
n=5 Participants • Acute Phase baseline S-K is the mean of 2 different pretreatment S-K values, recorded 60 (± 15 minutes) apart on Acute Phase Day 1.
|
|
Acute Phase baseline Serum Potassium
≥6.0 mmol/L
|
126 Participants
n=5 Participants • Acute Phase baseline S-K is the mean of 2 different pretreatment S-K values, recorded 60 (± 15 minutes) apart on Acute Phase Day 1.
|
PRIMARY outcome
Timeframe: 72 HoursPopulation: The Intent To Treat populations for the Acute Phase (AP-ITT) included subjects who received at least one dose of ZS with at least one S-K assessment after administration of Acute Phase ZS. Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases.
Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
Outcome measures
| Measure |
Proportion
n=748 Participants
Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
|
|---|---|
|
Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase
|
77.9 Percentage of participants
Interval 74.8 to 80.9
|
PRIMARY outcome
Timeframe: Study Days 85 to 365Population: The Extended Phase Intent To Treat populations (EP-ITT) included subjects who received at least one dose of ZS in the EP and have at least one S-K assessment after administration of Extended Phase ZS. Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases.
Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
Outcome measures
| Measure |
Proportion
n=646 Participants
Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
|
|---|---|
|
Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365
|
88.4 Percentage of participants
Interval 85.7 to 90.8
|
SECONDARY outcome
Timeframe: Study Days 85 to 365Population: Extended phase ITT population
Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population
Outcome measures
| Measure |
Proportion
n=646 Participants
Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
|
|---|---|
|
Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12
|
0.985 Proportion of participants
Interval 0.972 to 0.993
|
SECONDARY outcome
Timeframe: Study days 85 to 365Population: Extended phase ITT population
Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.
Outcome measures
| Measure |
Proportion
n=734 Participants
Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
|
|---|---|
|
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Acute Phase Baseline
|
5.59 mmol/L
Standard Deviation 0.425
|
|
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Extended Dosing Days 85 to 365/End of Study
|
4.66 mmol/L
Standard Deviation 0.379
|
|
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Extended Dosing Days 211 to 267
|
4.68 mmol/L
Standard Deviation 0.404
|
|
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Extended Dosing Days 295 to 365
|
4.62 mmol/L
Standard Deviation 0.401
|
Adverse Events
Acute Phase: ZS
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Extended Dosing Phase: ZS
Serious events: 161 serious events
Other events: 386 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Acute Phase: ZS
n=751 participants at risk
|
Extended Dosing Phase: ZS
n=746 participants at risk
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/751 • One year
|
1.9%
14/746 • One year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/751 • One year
|
1.5%
11/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/751 • One year
|
0.67%
5/746 • One year
|
|
Vascular disorders
Hypertension
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/751 • One year
|
0.94%
7/746 • One year
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/751 • One year
|
0.80%
6/746 • One year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Pyrexia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Investigations
Tropinin increased
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
General disorders
Asthenia
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/751 • One year
|
1.1%
8/746 • One year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Chest pain
|
0.00%
0/751 • One year
|
1.5%
11/746 • One year
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Vascular disorders
Peripheral arterial occulsive disease
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/751 • One year
|
0.54%
4/746 • One year
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
|
Infections and infestations
Abscess limb
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Social circumstances
Dependence on enabling machine or device
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/751 • One year
|
1.1%
8/746 • One year
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/751 • One year
|
0.67%
5/746 • One year
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Vascular disorders
Hypotension
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Impaired healing
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Nervous system disorders
Syncope
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Local swelling
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Sepsis
|
0.13%
1/751 • One year
|
0.40%
3/746 • One year
|
|
Infections and infestations
Appendicitis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Generalised oedema
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/751 • One year
|
0.40%
3/746 • One year
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/751 • One year
|
0.27%
2/746 • One year
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/746 • One year
|
0.13%
1/746 • Number of events 751 • One year
|
|
Cardiac disorders
Palpitations
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Gangrene
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
General disorders
Necrosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Nervous system disorders
Presyncope
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Staphylococcal sepsis
|
0.13%
1/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Nervous system disorders
Headache
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Influenza
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Heart injury
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Pericarditis uraemic
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Viral infection
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Psychiatric disorders
Depression
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/751 • One year
|
0.13%
1/746 • One year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/751 • One year
|
0.54%
4/746 • One year
|
Other adverse events
| Measure |
Acute Phase: ZS
n=751 participants at risk
|
Extended Dosing Phase: ZS
n=746 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/751 • One year
|
5.6%
42/746 • One year
|
|
Vascular disorders
Hypertension
|
0.13%
1/751 • One year
|
10.5%
78/746 • One year
|
|
General disorders
Oedema peripheral
|
0.13%
1/751 • One year
|
9.7%
72/746 • One year
|
|
Gastrointestinal disorders
Nausea
|
0.53%
4/751 • One year
|
7.5%
56/746 • One year
|
|
Gastrointestinal disorders
Constipation
|
0.27%
2/751 • One year
|
6.2%
46/746 • One year
|
|
Infections and infestations
Urinary tract infection
|
0.40%
3/751 • One year
|
7.4%
55/746 • One year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/751 • One year
|
5.0%
37/746 • One year
|
Additional Information
AstraZeneca Clinical Study Information Center
ZS Pharma, Inc
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee ZS Pharma has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER