HyperkalemiaPhase 4NCT03781089
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
A Phase 4 study testing Patiromer Oral Powder Product in people with Hyperkalemia and End Stage Renal Disease, run by Duke University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, End Stage Renal Disease
- What is being tested?
- Patiromer Oral Powder Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 15 Mar 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females, age at least 18 years
- ESRD treated with thrice-weekly HD for ≥ 6 months.
- At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months
- Current use of dialysate with potassium concentration ≤ 2 mEq/L
- Typical consumption of at least two meals per day
- Have received customary dietary instruction over prior month
- Considered by the treating physician(s) to be in otherwise stable clinical condition.
- If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.
Who cannot join
- Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
- Life expectancy < 3 months
- Dialysis-dependent for less than 6 months
- Non-elective hospitalization in prior 3 months
- Currently prescription of oral potassium supplements
- In the prior 3 months, therapy with oral potassium-lowering medication
Show all 12Show fewer
- Underlying severe gastrointestinal disorders, including history of ischemic bowel.
- Corrected serum calcium concentration > 10.5 mg/dL in prior three months
- Anticipated kidney transplant within the next 3 months
- Prisoners or others who are involuntarily incarcerated or detained
- Pregnant, breastfeeding, or considering pregnancy.
- Participation in a clinical trial of an experimental treatment within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)
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.
Read the detailed description
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.
- Conditions
- Hyperkalemia, End Stage Renal Disease
- Being tested
- Patiromer Oral Powder Product
- Keywords
- Hemodialysis
- Medical subject headings
- Hyperkalemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patiromer Oral Powder ProductDrug
Also called Valtressa
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
| Study group | Role | What they receive |
|---|---|---|
| Patiromer Oral Powder Product | Experimental | 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. Receives: Drug: Patiromer Oral Powder Product |
| Usual care arm | No intervention | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (11)
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.
Measured: 4 weeks
Median Daily Dose of Patiromer That Was Given in Treatment Arm
Measured: 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
Measured: 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).
Measured: 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).
Measured: Week 4
Number of Participants Who Completed All Study Visits
To determine feasibility of a large-scale hemodialysis-based trial.
Measured: 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.
Measured: 4 weeks
Change in Serum Albumin Concentration
To determine the between-group differences in serum albumin concentrations.
Measured: 4 weeks
Change in Parathyroid Hormone (PTH) Concentration
To determine the between-group differences in PTH concentrations.
Measured: 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
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Jun 2019
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 patients (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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- John P Middleton, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781089
- Sponsor's protocol ID
- Pro00088688
- Status last verified
- May 2025
- First submitted
- 18 Dec 2018
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant level data will not be shared.
Publications
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
PubMed 32588430