A Phase 4 interventional study of Patiromer Oral Powder Product in Hyperkalemia and End Stage Renal Disease, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Duke University · Phase 4, Interventional, and Prevention
The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 study participants (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.
This is a proof of concept study, to determine whether administration of patiromer has the potential to change the risk category for ESRD patients who are on conventional HD schedules. In addition, the study will develop and pilot study procedures that could be implemented in a large-scale clinical trial. By nature of the limited size of the study, the power of the trial will be limited. Reducing serum potassium with the use of low dialysate potassium is actually associated with an increased risk of sudden cardiac death. Furthermore, HD patients already carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic hyperkalemia.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 36 is below the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L.
Drug: Patiromer Oral Powder Product
Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Also known as: Valtressa
Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
Time frame: Week 4
Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
Time frame: 4 weeks
Median Daily Dose of Patiromer That Was Given in Treatment Arm
Time frame: Week 3
Number of Additional Hemodialysis Treatments Due to Hyperkalemia
To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia
Time frame: 4 weeks
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline
Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
Time frame: Baseline
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4
Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
Time frame: Week 4
Number of Participants Who Completed All Study Visits
To determine feasibility of a large-scale hemodialysis-based trial.
Time frame: 4 weeks
Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours
PVCs are irregular contractions that start in the ventricles instead of the atria.
Time frame: 4 weeks
Change in Serum Albumin Concentration
To determine the between-group differences in serum albumin concentrations.
Time frame: 4 weeks
Change in Parathyroid Hormone (PTH) Concentration
To determine the between-group differences in PTH concentrations.
Time frame: 4 weeks
Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued
To determine the change in serum potassium concentration two weeks after study drug is discontinued
Time frame: 6 weeks
Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued
To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued
Time frame: 6 weeks
Potential participants were identified from a population of individuals who had ESKD and were maintained on thrice-weekly hemodialysis at five outpatient clinics.
| Milestone | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Started | 17 | 16 |
| Completed | 16 | 15 |
| Not completed | 1 | 1 |
| Withdrew: Constipation | 1 | 0 |
| Withdrew: Positive pregnancy test | 0 | 1 |
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
| episodes | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L | 13 | 41 |
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
| episodes per participant | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant | 0 (0 to 3) | 3 (0 to 6) |
| grams/day | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Median Daily Dose of Patiromer That Was Given in Treatment Arm | 8.4 ± 0 | — |
To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia
No measurements were reported for this outcome.
Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
| Participants | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Premature ventricular contractions | 4 | 2 |
| Non-sustained VT events | 2 | 2 |
| Atrial fibrillation | 2 | 2 |
| Bradycardia events | 0 | 0 |
Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
| Participants | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Premature ventricular contractions | 2 | 4 |
| Non-sustained VT events | 3 | 2 |
| Atrial fibrillation | 2 | 1 |
| Bradycardia events | 0 | 1 |
To determine feasibility of a large-scale hemodialysis-based trial.
| Participants | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Number of Participants Who Completed All Study Visits | 16 | 15 |
PVCs are irregular contractions that start in the ventricles instead of the atria.
| Participants | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours | 2 | 4 |
To determine the between-group differences in serum albumin concentrations.
No measurements were reported for this outcome.
To determine the between-group differences in PTH concentrations.
No measurements were reported for this outcome.
To determine the change in serum potassium concentration two weeks after study drug is discontinued
No measurements were reported for this outcome.
To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued
No measurements were reported for this outcome.
Collected over Up to 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patiromer Oral Powder Product | 0/17 (0%) | 2/17 (11.8%) | 5/17 (29.4%) |
| Usual Care Arm | 0/16 (0%) | 2/16 (12.5%) | 5/16 (31.3%) |
| Event | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Arrhythmia (A-Fib)Cardiac disorders | 0/17 | 1/16 |
| Admitted for dry gangrene and lower extremity wound infection secondary to chronic limb ischemiaInfections and infestations | 0/17 | 1/16 |
| Admitted for Altered Mental Status secondary to cefepime neurotoxicityPsychiatric disorders | 0/17 | 1/16 |
| Hospitalization for new vascular accessSurgical and medical procedures | 1/17 | 0/16 |
| Thrombosis of arteriovenousfistulaVascular disorders | 1/17 | 0/16 |
| Event | Patiromer Oral Powder Product | Usual Care Arm |
|---|---|---|
| Pain from permcath placementSurgical and medical procedures | 0/17 | 1/16 |
| Skin sensitivity to Holter patchSkin and subcutaneous tissue disorders | 0/17 | 1/16 |
| Boil under left armSkin and subcutaneous tissue disorders | 0/17 | 1/16 |
| ScabiesSkin and subcutaneous tissue disorders | 0/17 | 1/16 |
| Hospitalization for amputationSurgical and medical procedures | 0/17 | 1/16 |
| ParasthesiasNervous system disorders | 1/17 | 0/16 |
| ConstipationGastrointestinal disorders | 1/17 | 0/16 |
| ItchingSkin and subcutaneous tissue disorders | 1/17 | 0/16 |
| Bloody stools/diarrheaGastrointestinal disorders | 1/17 | 0/16 |
| Hospitalization for new vascular accessSurgical and medical procedures | 1/17 | 0/16 |
| Age, Continuous(years) | Patiromer Oral Powder Product | Usual Care Arm | Total |
|---|---|---|---|
| Mean | 54.1 ± 10.7 | 58.5 ± 11.1 | 56.2 ± 11.0 |
| Sex: Female, Male(Participants) | Patiromer Oral Powder Product | Usual Care Arm | Total |
|---|---|---|---|
| Female | 5 | 10 | 15 |
| Male | 12 | 6 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Patiromer Oral Powder Product | Usual Care Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 15 | 15 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patiromer Oral Powder Product | Usual Care Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 14 | 27 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Patiromer Oral Powder Product | Usual Care Arm | Total |
|---|---|---|---|
| United States | 17 | 16 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Participant level data will not be shared.
Ran from Jun 2019 to primary completion in Mar 2023, 44 months.
Results were first posted in May 2025, 2 years 2 months after primary completion.
Of 16 phase 4 interventional studies under Hyperkalemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 44. This study's 44 months is above that.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Patiromer