Trial Outcomes & Findings for Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia (NCT NCT01866709)

NCT ID: NCT01866709

Last Updated: 2014-09-03

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: First 48 hours
• Results posted on: 2014-09-03

Participant Flow

Participant milestones

Measure	Sodium Polystyrene Sulfonate 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)	Silicified Microcrystalline Cellulose 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)
Overall Study STARTED	15	17
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Sodium Polystyrene Sulfonate 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)	Silicified Microcrystalline Cellulose 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)
Overall Study Adverse Event	1	0

Baseline Characteristics

Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia

Baseline characteristics by cohort

Measure	Sodium Polystyrene Sulfonate n=15 Participants 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	Silicified Microcrystalline Cellulose n=17 Participants 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 n=32 Participants Total of all reporting groups
Age, Continuous	71.1 years n=5 Participants	70.5 years n=7 Participants	70.8 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: First 48 hours

Population: Study prematurely terminated for safety reasons; no statistical analyses were conducted.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 48 hours

Population: Study was prematurely terminated for safety reasons; no statistical analyses were conducted.

Outcome measures

Outcome data not reported

Adverse Events

Sodium Polystyrene Sulfonate

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Silicified Microcrystalline Cellulose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sodium Polystyrene Sulfonate n=15 participants at risk 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.	Silicified Microcrystalline Cellulose n=17 participants at risk 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.
Cardiac disorders Prolonged QT Interval	6.7% 1/15 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Cardiac disorders Atrial Fibrillation	6.7% 1/15 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.

Other adverse events

Measure	Sodium Polystyrene Sulfonate n=15 participants at risk 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.	Silicified Microcrystalline Cellulose n=17 participants at risk 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.
Cardiac disorders ST elevation	6.7% 1/15 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Gastrointestinal disorders Bloating	6.7% 1/15 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Gastrointestinal disorders Diarrhea	26.7% 4/15 • Number of events 6 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	17.6% 3/17 • Number of events 3 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Gastrointestinal disorders Flatulence	20.0% 3/15 • Number of events 3 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	5.9% 1/17 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	5.9% 1/17 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Gastrointestinal disorders Stomach cramps	13.3% 2/15 • Number of events 2 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.	0.00% 0/17 • Each study visit: Days 1, 2 and 9 Participants were solicited for adverse events by systematic regular investigator assessment.

Additional Information

Henrik Rasmussen, MD, PhD

ZS Pharma, Inc

Phone: 443-699-5230

Email: hrasmussen@zspharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot publish any results related to the study without prior written approval of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER