Trial Outcomes & Findings for Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE) (NCT NCT02933450)

NCT ID: NCT02933450

Last Updated: 2019-05-09

Results Overview

serial serum potassium levels will be graphed and compared between the 2 groups

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2019-05-09

Participant Flow

Participant milestones

Measure	Patiromer Single dose of Patiromer 25.2 g + Standard of Care	Standard of Care Standard of Care
Overall Study STARTED	20	23
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patiromer Group n=15 Participants Single dose of Patiromer 25.2 g + Standard of Care	Standard of Care Group n=15 Participants Standard of Care	Total n=30 Participants Total of all reporting groups
Age, Continuous	41 years n=15 Participants	48 years n=15 Participants	43 years n=30 Participants
Sex: Female, Male Female	5 Participants n=15 Participants	8 Participants n=15 Participants	13 Participants n=30 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	7 Participants n=15 Participants	17 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 hours

serial serum potassium levels will be graphed and compared between the 2 groups

Outcome measures

Measure	Patiromer n=15 Participants Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy	Standard of Care n=15 Participants subjects receiving standard of care therapy
Efficacy of Patiromer in Reducing Serum Potassium 2 hr	5.9 mEq/L Interval 5.67 to 6.2	6.47 mEq/L Interval 6.21 to 6.73
Efficacy of Patiromer in Reducing Serum Potassium 4 hr	5.73 mEq/L Interval 5.5 to 6.02	6.04 mEq/L Interval 5.77 to 6.3
Efficacy of Patiromer in Reducing Serum Potassium 1 hr	6.17 mEq/L Interval 5.94 to 6.46	6.6 mEq/L Interval 6.33 to 6.86
Efficacy of Patiromer in Reducing Serum Potassium 6 hr	5.81 mEq/L Interval 5.51 to 6.16	6.27 mEq/L Interval 5.97 to 6.58

SECONDARY outcome

Timeframe: 6 hours

adverse events will be recorded and compared between the 2 groups

Outcome measures

Measure	Patiromer n=14 Participants Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy	Standard of Care n=15 Participants subjects receiving standard of care therapy
Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. Total	4 Participants	5 Participants
Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. GI side effects	1 Participants	2 Participants
Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. Hypoglycemia	3 Participants	3 Participants
Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. Hypomagnesemia	0 Participants	0 Participants

Adverse Events

Patiromer

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patiromer n=15 participants at risk Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy	Standard of Care n=15 participants at risk subjects receiving standard of care therapy
Gastrointestinal disorders GI Side Effects	6.7% 1/15 • Number of events 1 • Adverse events were collected up to 6hrs	13.3% 2/15 • Number of events 2 • Adverse events were collected up to 6hrs
General disorders Hypoglycemia	20.0% 3/15 • Number of events 3 • Adverse events were collected up to 6hrs	20.0% 3/15 • Number of events 3 • Adverse events were collected up to 6hrs

Additional Information

Dr Zubaid Rafiue

Emergency Department, Baylor College of Medicine

Phone: 7138732626

Email: zubaidrafique@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place