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Potassium Binder

Patiromer Oral Powder Product for Kidney Failure

Phase 4
Waitlist Available
Led By John P Middleton, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is testing whether a once-daily dose of patiromer will reduce the frequency of hyperkalemic episodes in ESRD patients receiving conventional hemodialysis.

Eligible Conditions
  • Kidney Failure
  • Hyperkalemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of episodes of serum K ≥ 5.5 mEq/L
Secondary outcome measures
Average dose of patiromer that was given in treatment arm
Change percentage in serum phosphorus concentration two weeks after study drug has been discontinued.
Change percentage in serum potassium concentration two weeks after study drug is discontinued.
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patiromer Oral Powder ProductExperimental Treatment1 Intervention
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.
Group II: Usual care armActive Control1 Intervention
Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patiromer Oral Powder Product
2019
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,565 Total Patients Enrolled
4 Trials studying Kidney Failure
1,595 Patients Enrolled for Kidney Failure
Vifor PharmaIndustry Sponsor
54 Previous Clinical Trials
1,130,116 Total Patients Enrolled
John P Middleton, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the United States Food and Drug Administration (FDA) greenlighted Patiromer Oral Powder Product?

"The safety of Patiromer Oral Powder Product was assessed to be a 3, due to the fact it is in its fourth clinical trial phase and has already been approved."

Answered by AI

What is the scope of participants in this research?

"This clinical trial is no longer seeking participants. It was initially announced on June 20th, 2019 and last updated June 10th, 2022. If you're searching for other studies related to hyperkalemia there are 601 active trials while Patiromer Oral Powder Product has 4 presently open studies."

Answered by AI

Could you detail the prior research done on Patiromer Oral Powder Product?

"Presently, 4 Patiromer Oral Powder Product trials are still in progress with 2 of them at Phase 3. These studies take place in 25 disparate locations, most notably Durham, North carolina."

Answered by AI

Is this research initiative open for registration at the moment?

"Unfortunately, according to clinicaltrials.gov this investigation is not presently enrolling patients; the trial was initially posted on June 20th 2019 and last updated on June 10th 2022. Nevertheless, there are 605 other active studies that may be seeking participants at this juncture."

Answered by AI
~6 spots leftby Mar 2025