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Trial record 19 of 119 for:    ZIRCONIUM

Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

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: NCT02163499
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
ZS Pharma, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Hyperkalemia
Intervention Drug: Sodium Zirconium Cyclosilicate
Enrollment 751
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Subject Disposition
Hide Arm/Group Description All Screened Subjects
Period Title: Acute Phase: ZS 10 g TID
Started 751
Completed 746
Not Completed 5
Reason Not Completed
Participant's Compliance             1
Hypo- or Hyperkalemia             1
Protocol Violation             1
Physician Decision             1
Withdrawal by Subject             1
Period Title: Extended Dosing Phase: ZS
Started 746
Completed 466
Not Completed 280
Reason Not Completed
Adverse Event             51
Expected Progression of CKD             40
Hypokalemia             9
Sponsor's Decision             5
Met ECG Withdrawal Criteria             7
Withdrawal by Subject             81
Physician Decision             8
Lost to Follow-up             31
Protocol Violation             2
Death             8
Subject Compliance             17
Hyperkalemia             5
Various reasons             16
Arm/Group Title Acute Phase: ZS
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 751
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 751 participants
63.6  (13.03)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
Female 303
Male 448
[1]
Measure Description: Gender
[2]
Measure Analysis Population Description: Acute Phase Safety Population
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
Asian 25
Native Hawaiian or Other Pacific Islander 3
Black or African American 89
White 624
Other 10
Use of RAAS inhibitor medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
527
[1]
Measure Analysis Population Description: Acute Phase - Safety Population
Co-morbidities at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
Diabetes mellitus 471
Chronic kidney disease 513
Heart Failure 285
[1]
Measure Analysis Population Description: Acute Phase - Safety Population
Baseline eGFR  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
<15 46
15-<30 243
30-<60 263
≥60 190
Missing 9
Acute Phase baseline Serum Potassium   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants
<5.5 mmol/L 287
5.5<6.0 mmol/L 338
≥6.0 mmol/L 126
[1]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title 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
Hide Description 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
Time Frame 72 Hours
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Percentage
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 748
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.9
(74.8 to 80.9)
2.Primary Outcome
Title Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365
Hide Description Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
Time Frame Study Days 85 to 365
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Percentage
Hide Arm/Group Description:
Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
Overall Number of Participants Analyzed 646
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
88.4
(85.7 to 90.8)
3.Secondary Outcome
Title Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12
Hide Description Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population
Time Frame Study Days 85 to 365
Hide Outcome Measure Data
Hide Analysis Population Description
Extended phase ITT population
Arm/Group Title Proportion
Hide Arm/Group Description:
Proportion of subjects with mean S-K between 3.5 and 5.5 mmol/L, inclusive months 3 to 12
Overall Number of Participants Analyzed 646
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.985
(0.972 to 0.993)
4.Secondary Outcome
Title Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Hide Description 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.
Time Frame Study days 85 to 365
Hide Outcome Measure Data
Hide Analysis Population Description
Extended phase ITT population
Arm/Group Title Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 734
Mean (Standard Deviation)
Unit of Measure: mmol/L
Acute Phase Baseline Number Analyzed 734 participants
5.59  (0.425)
Extended Dosing Days 85 to 365/End of Study Number Analyzed 646 participants
4.66  (0.379)
Extended Dosing Days 211 to 267 Number Analyzed 564 participants
4.68  (0.404)
Extended Dosing Days 295 to 365 Number Analyzed 512 participants
4.62  (0.401)
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acute Phase: ZS Extended Dosing Phase: ZS
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Acute Phase: ZS Extended Dosing Phase: ZS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/751 (0.00%)      8/746 (1.07%)    
Show Serious Adverse Events Hide Serious Adverse Events
Acute Phase: ZS Extended Dosing Phase: ZS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/751 (0.13%)      161/746 (21.58%)    
Blood and lymphatic system disorders     
Anaemia  1  0/751 (0.00%)  2/746 (0.27%) 
Cardiac disorders     
Cardiac failure congestive  1  0/751 (0.00%)  11/746 (1.47%) 
Acute myocardial infarction  1  0/751 (0.00%)  6/746 (0.80%) 
Cardiac failure  1  0/751 (0.00%)  4/746 (0.54%) 
Angina unstable  1  0/751 (0.00%)  3/746 (0.40%) 
Ventricular tachycardia  1  0/751 (0.00%)  2/746 (0.27%) 
Myocardial infarction  1  0/751 (0.00%)  3/746 (0.40%) 
Atrial fibrillation  1  0/751 (0.00%)  3/746 (0.40%) 
Bundle branch block right  1  0/751 (0.00%)  1/746 (0.13%) 
Myocarditis  1  0/751 (0.00%)  1/746 (0.13%) 
Cardiac arrest  1  0/751 (0.00%)  1/746 (0.13%) 
Aortic valve stenosis  1  0/751 (0.00%)  1/746 (0.13%) 
Coronary artery disease  1  0/751 (0.00%)  1/746 (0.13%) 
Cardiomyopathy  1  0/751 (0.00%)  1/746 (0.13%) 
Palpitations  1  0/751 (0.00%)  1/746 (0.13%) 
Heart injury  1  0/751 (0.00%)  1/746 (0.13%) 
Coronary artery stenosis  1  0/751 (0.00%)  1/746 (0.13%) 
Pericarditis uraemic  1  0/751 (0.00%)  1/746 (0.13%) 
Acute coronary syndrome  1  0/751 (0.00%)  1/746 (0.13%) 
Right ventricular failure  1  0/751 (0.00%)  1/746 (0.13%) 
Cardiac failure acute  1  0/751 (0.00%)  1/746 (0.13%) 
Angina pectoris  1  0/751 (0.00%)  1/746 (0.13%) 
Gastrointestinal disorders     
Ascites  1  0/751 (0.00%)  1/746 (0.13%) 
Gastric ulcer  1  0/751 (0.00%)  1/746 (0.13%) 
Gastrointestinal necrosis  1  0/751 (0.00%)  1/746 (0.13%) 
Constipation  1  0/751 (0.00%)  2/746 (0.27%) 
Peptic ulcer  1  0/751 (0.00%)  2/746 (0.27%) 
Pancreatitis  1  0/751 (0.00%)  1/746 (0.13%) 
Gastrointestinal haemorrhage  1  0/751 (0.00%)  1/746 (0.13%) 
Gastritis  1  0/751 (0.00%)  1/746 (0.13%) 
Oesophagitis  1  0/751 (0.00%)  1/746 (0.13%) 
General disorders     
Pyrexia  1  0/751 (0.00%)  1/746 (0.13%) 
Asthenia  1  0/751 (0.00%)  2/746 (0.27%) 
Chest pain  1  0/751 (0.00%)  11/746 (1.47%) 
Impaired healing  1  0/751 (0.00%)  1/746 (0.13%) 
Local swelling  1  0/751 (0.00%)  1/746 (0.13%) 
Generalised oedema  1  0/751 (0.00%)  1/746 (0.13%) 
Necrosis  1  0/751 (0.00%)  1/746 (0.13%) 
Hepatobiliary disorders     
Cholecystitis  1  0/751 (0.00%)  2/746 (0.27%) 
Infections and infestations     
Pneumonia  1  0/751 (0.00%)  14/746 (1.88%) 
Cellulitis  1  0/751 (0.00%)  7/746 (0.94%) 
Lobar pneumonia  1  0/751 (0.00%)  3/746 (0.40%) 
Osteomyelitis  1  0/751 (0.00%)  8/746 (1.07%) 
Pneumonia cryptococcal  1  0/751 (0.00%)  1/746 (0.13%) 
Diverticulitis  1  0/751 (0.00%)  1/746 (0.13%) 
Urinary tract infection  1  1/751 (0.13%)  4/746 (0.54%) 
Abscess limb  1  0/751 (0.00%)  1/746 (0.13%) 
Bacteraemia  1  0/751 (0.00%)  1/746 (0.13%) 
Gas gangrene  1  0/751 (0.00%)  1/746 (0.13%) 
Sepsis  1  1/751 (0.13%)  3/746 (0.40%) 
Appendicitis  1  0/751 (0.00%)  1/746 (0.13%) 
Bronchitis  1  0/751 (0.00%)  3/746 (0.40%) 
Pneumonia mycoplasmal  1  0/751 (0.00%)  1/746 (0.13%) 
Atypical pneumonia  1  0/751 (0.00%)  1/746 (0.13%) 
Gangrene  1  0/751 (0.00%)  1/746 (0.13%) 
Osteomyelitis acute  1  0/751 (0.00%)  1/746 (0.13%) 
Staphylococcal sepsis  1  1/751 (0.13%)  1/746 (0.13%) 
Diabetic foot infection  1  0/751 (0.00%)  1/746 (0.13%) 
Influenza  1  0/751 (0.00%)  1/746 (0.13%) 
Infective exacerbation of chronic obstructive airways disease  1  0/751 (0.00%)  1/746 (0.13%) 
Escherichia urinary tract infection  1  0/751 (0.00%)  1/746 (0.13%) 
Urosepsis  1  0/751 (0.00%)  1/746 (0.13%) 
Viral infection  1  0/751 (0.00%)  1/746 (0.13%) 
Lower respiratory tract infection  1  0/751 (0.00%)  1/746 (0.13%) 
Pharyngitis  1  0/751 (0.00%)  1/746 (0.13%) 
Gastrointestinal infection  1  0/751 (0.00%)  1/746 (0.13%) 
Gastroenteritis  1  0/751 (0.00%)  1/746 (0.13%) 
Injury, poisoning and procedural complications     
Lower limb fracture  1  0/751 (0.00%)  1/746 (0.13%) 
Ankle fracture  1  0/751 (0.00%)  1/746 (0.13%) 
Comminuted fracture  1  0/751 (0.00%)  1/746 (0.13%) 
Anaemia postoperative  1  0/751 (0.00%)  1/746 (0.13%) 
Toxicity to various agents  1  0/751 (0.00%)  1/746 (0.13%) 
Drug dose omission  1  0/751 (0.00%)  1/746 (0.13%) 
Pelvic fracture  1  0/751 (0.00%)  1/746 (0.13%) 
Femoral neck fracture  1  0/751 (0.00%)  1/746 (0.13%) 
Craniocerebral injury  1  0/751 (0.00%)  1/746 (0.13%) 
Limb injury  1  0/751 (0.00%)  1/746 (0.13%) 
Investigations     
Tropinin increased  1  0/751 (0.00%)  2/746 (0.27%) 
Electrocardiogram abnormal  1  0/751 (0.00%)  1/746 (0.13%) 
Metabolism and nutrition disorders     
Fluid overload  1  0/751 (0.00%)  3/746 (0.40%) 
Hyperkalaemia  1  0/751 (0.00%)  4/746 (0.54%) 
Hyperglycaemia  1  0/751 (0.00%)  1/746 (0.13%) 
Dehydration  1  0/751 (0.00%)  2/746 (0.27%) 
Gout  1  0/751 (0.00%)  1/746 (0.13%) 
Hypovolaemia  1  0/751 (0.00%)  1/746 (0.13%) 
Hypoglycaemia  1  0/751 (0.00%)  4/746 (0.54%) 
Musculoskeletal and connective tissue disorders     
Neuropathic arthropathy  1  0/751 (0.00%)  1/746 (0.13%) 
Lumbar spinal stenosis  1  0/751 (0.00%)  1/746 (0.13%) 
Arthralgia  1  0/751 (0.00%)  1/746 (0.13%) 
Chondrocalcinosis pyrophosphate  1  0/751 (0.00%)  1/746 (0.13%) 
Back pain  1  0/751 (0.00%)  1/746 (0.13%) 
Neck pain  1  0/751 (0.00%)  1/746 (0.13%) 
Osteoarthritis  1  0/751 (0.00%)  1/746 (0.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/751 (0.00%)  1/746 (0.13%) 
Intraductal proliferative breast lesion  1  0/751 (0.00%)  1/746 (0.13%) 
Metastases to lung  1  0/751 (0.00%)  1/746 (0.13%) 
Nervous system disorders     
Dysarthria  1  0/751 (0.00%)  1/746 (0.13%) 
Syncope  1  0/751 (0.00%)  2/746 (0.27%) 
Balance disorder  1  0/751 (0.00%)  1/746 (0.13%) 
Cerebrovascular accident  1  0/751 (0.00%)  3/746 (0.40%) 
Multiple sclerosis  1  0/751 (0.00%)  1/746 (0.13%) 
Transient ischaemic attack  1  0/751 (0.00%)  2/746 (0.27%) 
Presyncope  1  0/751 (0.00%)  1/746 (0.13%) 
Headache  1  0/751 (0.00%)  1/746 (0.13%) 
Psychiatric disorders     
Delirium  1  0/751 (0.00%)  1/746 (0.13%) 
Panic attack  1  0/751 (0.00%)  1/746 (0.13%) 
Depression  1  0/751 (0.00%)  1/746 (0.13%) 
Renal and urinary disorders     
Renal failure chronic  1  0/751 (0.00%)  4/746 (0.54%) 
Renal failure acute  1  0/751 (0.00%)  8/746 (1.07%) 
Cystitis haemorrhagic  1  0/751 (0.00%)  1/746 (0.13%) 
Azotaemia  1  0/751 (0.00%)  1/746 (0.13%) 
Haematuria  1  0/751 (0.00%)  1/746 (0.13%) 
Hydronephrosis  1  0/746 (0.00%)  1/746 (0.13%)  751
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/751 (0.00%)  5/746 (0.67%) 
Chronic obstructive pulmonary disease  1  0/751 (0.00%)  3/746 (0.40%) 
Pulmonary oedema  1  0/751 (0.00%)  3/746 (0.40%) 
Dyspnoea  1  0/751 (0.00%)  5/746 (0.67%) 
Respiratory failure  1  0/751 (0.00%)  3/746 (0.40%) 
Sleep apnoea syndrome  1  0/751 (0.00%)  1/746 (0.13%) 
Interstitial lung disease  1  0/751 (0.00%)  1/746 (0.13%) 
Hypoxia  1  0/751 (0.00%)  1/746 (0.13%) 
Pulmonary mass  1  0/751 (0.00%)  1/746 (0.13%) 
Asthma  1  0/751 (0.00%)  1/746 (0.13%) 
Pleural effusion  1  0/751 (0.00%)  1/746 (0.13%) 
Hypercapnia  1  0/751 (0.00%)  1/746 (0.13%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/751 (0.00%)  4/746 (0.54%) 
Diabetic foot  1  0/751 (0.00%)  2/746 (0.27%) 
Rash  1  0/751 (0.00%)  1/746 (0.13%) 
Social circumstances     
Dependence on enabling machine or device  1  0/751 (0.00%)  1/746 (0.13%) 
Surgical and medical procedures     
Leg amputation  1  0/751 (0.00%)  1/746 (0.13%) 
Vascular disorders     
Hypertension  1  0/751 (0.00%)  4/746 (0.54%) 
Malignant hypertension  1  0/751 (0.00%)  1/746 (0.13%) 
Peripheral arterial occulsive disease  1  0/751 (0.00%)  1/746 (0.13%) 
Deep vein thrombosis  1  0/751 (0.00%)  1/746 (0.13%) 
Hypertensive crisis  1  0/751 (0.00%)  1/746 (0.13%) 
Hypotension  1  0/751 (0.00%)  1/746 (0.13%) 
1
Term from vocabulary, MedDRA 19.0
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 5%
Acute Phase: ZS Extended Dosing Phase: ZS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/751 (1.46%)      386/746 (51.74%)    
Blood and lymphatic system disorders     
Anaemia  1  0/751 (0.00%)  42/746 (5.63%) 
Gastrointestinal disorders     
Nausea  1  4/751 (0.53%)  56/746 (7.51%) 
Constipation  1  2/751 (0.27%)  46/746 (6.17%) 
General disorders     
Oedema peripheral  1  1/751 (0.13%)  72/746 (9.65%) 
Infections and infestations     
Urinary tract infection  1  3/751 (0.40%)  55/746 (7.37%) 
Upper respiratory infection  1  0/751 (0.00%)  37/746 (4.96%) 
Vascular disorders     
Hypertension  1  1/751 (0.13%)  78/746 (10.46%) 
1
Term from vocabulary, MedDRA 19.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical Study Information Center
Organization: ZS Pharma, Inc
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: ZS Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02163499     History of Changes
Other Study ID Numbers: ZS-005
First Submitted: June 11, 2014
First Posted: June 13, 2014
Results First Submitted: March 28, 2018
Results First Posted: June 27, 2018
Last Update Posted: June 27, 2018