Trial Outcomes & Findings for An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis (NCT NCT02033317)
NCT ID: NCT02033317
Last Updated: 2021-05-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Day 1 and Day 8
Results posted on
2021-05-12
Participant Flow
The study population consisted of participants on hemodialysis between the ages of 18 and 70 years, with pre-dialysis serum potassium levels of at least 5.5 mmol/L prior to the study.
Participant milestones
| Measure |
Patiromer
15 grams/day (5 grams 3 times daily) patiromer administered orally
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
Baseline characteristics by cohort
| Measure |
Patiromer
n=6 Participants
15 grams/day (5 grams 3 times daily) patiromer administered orally
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Outcome measures
| Measure |
Patiromer
n=6 Participants
15 grams/day (5 grams 3 times daily) patiromer administered orally
|
|---|---|
|
Change in Serum Potassium (Day 1 to Day 8)
|
-0.23 mmol/L
Standard Deviation 0.327
|
PRIMARY outcome
Timeframe: Day -7 Through Day -1 and Day 1 Through Day 7Outcome measures
| Measure |
Patiromer
n=6 Participants
15 grams/day (5 grams 3 times daily) patiromer administered orally
|
|---|---|
|
Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)
|
359 mg/Day
Standard Deviation 277
|
Adverse Events
Patiromer
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patiromer
n=6 participants at risk
15 grams/day (5 grams 3 times daily) patiromer administered orally.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Rigidity
|
16.7%
1/6 • Up to 10 days after Day 8 or last patiromer dose, whichever was earlier.
Participants who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Up to 10 days after Day 8 or last patiromer dose, whichever was earlier.
Participants who received at least one dose of trial medication.
|
|
Infections and infestations
Furuncle
|
16.7%
1/6 • Up to 10 days after Day 8 or last patiromer dose, whichever was earlier.
Participants who received at least one dose of trial medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreements generally provide that PI cannot publish single site data before publication of the multi-site publication, unless 1 year has elapsed since completion of the study at all sites. Thereafter, PI may publish provided that PI shall: provide a copy of the publication to sponsor at least 60 days in advance of submission for publication; delete sponsor's confidential information as requested; and delay publication up to an additional 90 days to permit protection of intellectual property.
- Publication restrictions are in place
Restriction type: OTHER