Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia

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: NCT01866709
Recruitment Status : Terminated (Risk/benefit determination showed study revealed negative safety issues.)
First Posted : May 31, 2013
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
ZS Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Hyperkalemia
Interventions Drug: Sodium polystyrene sulfonate
Drug: Silicified microcrystalline cellulose
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Hide Arm/Group Description

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Enrollment: Assessed for eligibility (n= 36 )

Excluded (n= 4)

  • Not meeting inclusion criteria (n= 4 )
  • Declined to participate (n= 0)
  • Other reasons (n= 0 )

Randomized (n= 32 )

Allocated to intervention (n= 15 ): ACTIVE

  • Received allocated intervention (n= 15)
  • Did not receive allocated intervention (give reasons) (n= 0 )

Lost to follow-up (give reasons) (n= 0 )

Discontinued intervention before study terminated (n= 1): non-serious adverse event

Analyzed (n= 0)

◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Enrollment: Assessed for eligibility (n= 36 )

Excluded (n= 4)

  • Not meeting inclusion criteria (n= 4 )
  • Declined to participate (n= 0)
  • Other reasons (n= 0 )

Randomized (n= 32 )

Allocated to intervention (n= 17): PLACEBO

  • Received allocated intervention (n= 17 )
  • Did not receive allocated intervention (give reasons) (n= 0)

Lost to follow-up (give reasons) (n= 0 )

Analyzed (n= 0)

◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)

Period Title: Overall Study
Started 15 17
Completed 14 17
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose Total
Hide Arm/Group Description

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Sodium polystyrene sulfonate (ACTIVE)

Total Study Enrollment: Assessed for eligibility (n= 36 )

Excluded (n= 4)

  • Not meeting inclusion criteria (n= 4 )
  • Declined to participate (n= 0)
  • Other reasons (n= 0 )

Total Randomized (n= 32 )

Allocated to intervention (n= 15 ): ACTIVE

  • Received allocated intervention (n= 15)
  • Did not receive allocated intervention (give reasons) (n= 0 )

Lost to follow-up (give reasons) (n= 0 )

Discontinued intervention before study terminated (n= 1): non-serious adverse event

Analysed (n= 0)

◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Silicified microcrystalline cellulose (PLACEBO)

Total Study Enrollment: Assessed for eligibility (n= 36 )

Excluded (n= 4)

  • Not meeting inclusion criteria (n= 4 )
  • Declined to participate (n= 0)
  • Other reasons (n= 0 )

Total Randomized (n= 32 )

Allocated to intervention (n= 17): PLACEBO

  • Received allocated intervention (n= 17 )
  • Did not receive allocated intervention (give reasons) (n= 0)

Lost to follow-up (give reasons) (n= 0 )

Discontinued intervention (give reasons) (n= 0)

Analysed (n= 0)

◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons

Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
Mean i-STAT serum potassium values between 5.0 - 6.5 mmol/l inclusive at screening (Study Day 0) plus meeting inclusion/exclusion eligibility criteria.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
71.1
(53 to 83)
70.5
(50 to 88)
70.8
(50 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
6
  40.0%
7
  41.2%
13
  40.6%
Male
9
  60.0%
10
  58.8%
19
  59.4%
1.Primary Outcome
Title Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.
Hide Description To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.
Time Frame First 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study prematurely terminated for safety reasons; no statistical analyses were conducted.
Arm/Group Title Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Hide Arm/Group Description:

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Sodium polystyrene sulfonate

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Silicified microcrystalline cellulose

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.
Hide Description [Not Specified]
Time Frame First 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated for safety reasons; no statistical analyses were conducted.
Arm/Group Title Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Hide Arm/Group Description:

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Sodium polystyrene sulfonate

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Silicified microcrystalline cellulose

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Each study visit: Days 1, 2 and 9
Adverse Event Reporting Description Participants were solicited for adverse events by systematic regular investigator assessment.
 
Arm/Group Title Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Hide Arm/Group Description

Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment.

Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.

Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment.

All-Cause Mortality
Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      0/17 (0.00%)    
Cardiac disorders     
Prolonged QT Interval  1  1/15 (6.67%)  1 0/17 (0.00%)  0
Atrial Fibrillation  1  1/15 (6.67%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1E)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Polystyrene Sulfonate Silicified Microcrystalline Cellulose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/15 (46.67%)      3/17 (17.65%)    
Cardiac disorders     
ST elevation  1  1/15 (6.67%)  1 0/17 (0.00%)  0
Gastrointestinal disorders     
Bloating  1  1/15 (6.67%)  1 0/17 (0.00%)  0
Diarrhea  1  4/15 (26.67%)  6 3/17 (17.65%)  3
Flatulence  1  3/15 (20.00%)  3 1/17 (5.88%)  1
Nausea  1  2/15 (13.33%)  2 1/17 (5.88%)  1
Stomach cramps  1  2/15 (13.33%)  2 0/17 (0.00%)  0
Nervous system disorders     
Headache  1  1/15 (6.67%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1E)
Due to the high frequency of adverse events in the SPS group, the independent Data Monitoring Committee (iDMC) recommended termination of the study.
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.
The PI cannot publish any results related to the study without prior written approval of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henrik Rasmussen, MD, PhD
Organization: ZS Pharma, Inc
Phone: 443-699-5230
EMail: hrasmussen@zspharma.com
Layout table for additonal information
Responsible Party: ZS Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01866709    
Other Study ID Numbers: SPS-001
First Submitted: May 28, 2013
First Posted: May 31, 2013
Results First Submitted: August 20, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014