ESRDPhase 2NCT03326583

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

A Phase 2 study testing Patiromer in people with ESRD and Hyperkalemia, run by Dominic Raj at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: ESRD, Hyperkalemia, End Stage Renal Disease
What is being tested?: Patiromer
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2017to 31 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects on stable hemodialysis for more than 90 days.
Age 18-85 years.
Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than 2 occasions during the previous 3 months.

Who cannot join

Use of pre- or probiotics during the past 2 months
Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.
Presence of chronic wound infection and osteomyelitis
Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
Liver cirrhosis or chronic active hepatitis
Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone > 10 mg in the last 3 months

Show all 12Show fewer

Anticipated kidney transplant within 9 months
Expected survival < 9 months
Pregnancy, anticipated pregnancy, or breastfeeding
Incarceration
Participation in another intervention study
severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months

Trial locations and contacts

1 site in 1 country.

United States1 site

DaVita K Street
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

Conditions: ESRD, Hyperkalemia, End Stage Renal Disease
Being tested: Patiromer
Keywords: End Stage Renal Disease, ESRD, Hyperkalemia
Medical subject headings: Kidney Failure, Chronic, Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PatiromerDrug
Patiromer will be orally self-administered by participants.

Study groups in NCT03326583
Study group	Role	What they receive
Patiromer	Experimental	This arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase. Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication. Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected. Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected. Receives: Drug: Patiromer

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)
The Gastrointestinal Symptom Rating Scale was used to measures any potential side effects due to study medication. Survey was administered at Wk 1, Wk 8, Wk 14, and Wk 20.
For symptoms (abdomen pain - diarrhea) a score of 0 indicates "no discomfort", 1 = "mild discomfort", 2=moderate, 3=severe; higher score means a worse outcome
For stool form, 1=Well formed, 2=Semi formed, 3= Loose, 4= Liquid;higher score means a worse outcome
For number of stools per day, 1= <1, 2=1 or 2, 3=3 or 4, 4=5 or 6,5= 7 or more; higher score means a worse outcome
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Serum Potassium Level Through 12 Weeks of Treatment
Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Changes in Blood Chemistry During the Study
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Stool Electrolytes During the Study Phases
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

Secondary outcomes (2)

Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer
Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by untargeted and targeted metabolomics for stool and serum metabolome profiles.
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile.
Measured: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201731 Dec 2020

First posted31 Oct 2017
Study start1 Nov 2017
Primary completion31 Dec 2020
Study completion31 Dec 2020

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 ESRDStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03326583
Sponsor's protocol ID: 071738
Status last verified: Apr 2023
First submitted: 6 Oct 2017
Last updated: 9 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.
PubMed 32750456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ESRD trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
ClinicalTrials.gov ID: NCT03326583
Acronym / sponsor ID: 071738
Conditions: ESRD, Hyperkalemia, End Stage Renal Disease
Keywords: End Stage Renal Disease, ESRD, Hyperkalemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Dominic RajUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 31 Oct 2017 (actual)
Results: Posted 22 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patiromer	Experimental	Drug: PatiromerThis arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase. Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication. Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected. Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects on stable hemodialysis for more than 90 days.
Age 18-85 years.
Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than 2 occasions during the previous 3 months.

Key exclusion criteria (12 listed)

Use of pre- or probiotics during the past 2 months
Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.
Presence of chronic wound infection and osteomyelitis
Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
Liver cirrhosis or chronic active hepatitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PatiromerPatiromer will be orally self-administered by participants.	Drug	Patiromer

Primary outcome

Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
The Gastrointestinal Symptom Rating Scale was used to measures any potential side effects due to study medication. Survey was administered at Wk 1, Wk 8, Wk 14, and Wk 20. For symptoms (abdomen pain - diarrhea) a score of 0 indicates "no discomfort", 1 = "mild discomfort", 2=moderate, 3=severe; higher score means a worse outcome For stool form, 1=Well formed, 2=Semi formed, 3= Loose, 4= Liquid;higher score means a worse outcome For number of stools per day, 1= <1, 2=1 or 2, 3=3 or 4, 4=5 or 6,5= 7 or more; higher score means a worse outcome
Serum Potassium Level Through 12 Weeks of Treatment
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20
Changes in Blood Chemistry During the Study
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Stool Electrolytes During the Study Phases
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

2 secondary outcomes

Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)

Results and safety

Results posted to the registry on 22 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patiromer	27	26

Primary outcome: Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)

Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Pre-Treatment n = 27	Treatment n = 24	Post-Treatment n = 24
Abdomen Pain	.24 (.04 to .44)	.23 (0 to .51)	.16 (0 to .32)
Heartburn	.08 (0 to .17)	.31 (.02 to .59)	.13 (0 to .32)
Acid Reflux	.22 (.03 to .41)	.35 (.06 to .64)	.30 (.04 to .56)
Hunger Pains	0 (0 to 0)	.19 (0 to .38)	.04 (0 to .13)
Nausea	.44 (.14 to .75)	.42 (.11 to .74)	.14 (0 to .39)
Rumbling Stomach	.34 (.14 to .54)	.23 (0 to .48)	.31 (0 to .62)
Bloated	.14 (0 to .28)	.12 (0 to .24)	.14 (0 to .28)
Burping	.13 (.02 to .25)	.08 (0 to .18)	.26 (0 to .57)

Pre-Treatment vs Treatment vs Post-Treatment: p = .05, Fisher Exact

Primary outcome: Serum Potassium Level Through 12 Weeks of Treatment

Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment). Mean (95% Confidence Interval). Unit: mEq/L

Measure	Pre-Treatment n = 27	Intervention: Treatment n = 24	Post-Treatment n = 24
Value	5.7 (5.4 to 5.9)	5.1 (4.9 to 5.2)	5.4 (5.2 to 5.6)

Pre-Treatment vs Intervention: Treatment vs Post-Treatment: p = .05, Mixed Models Analysis

Primary outcome: Changes in Blood Chemistry During the Study

Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment). Mean (95% Confidence Interval). Unit: mg/dl

Measure	Pre-Treatment n = 27	Treatment n = 24	Post-Treatment n = 24
Blood Urea Nitrogen	62.2 (56.9 to 67.5)	62.6 (57.3 to 67.9)	59.0 (54.1 to 64.0)
Creatinine	10.4 (9.7 to 11.0)	10.6 (9.9 to 11.4)	10.5 (9.9 to 11.1)
Sodium	138.4 (137.3 to 139.5)	138.5 (137.5 to 139.6)	139.2 (135.7 to 142.6)
Potassium	5.7 (5.4 to 5.9)	5.1 (4.9 to 5.2)	5.4 (5.2 to 5.6)
Chloride	95.2 (94.0 to 96.5)	95.1 (94.0 to 96.3)	95.8 (94.6 to 97.0)
Carbon Dioxide	20.3 (19.4 to 21.2)	20.0 (19.1 to 20.9)	20.6 (19.5 to 21.7)
Calcium	8.9 (8.7 to 9.1)	9.1 (8.9 to 9.4)	8.7 (8.5 to 8.9)
Phosphate	6.0 (5.3 to 6.7)	6.0 (5.4 to 6.7)	6.3 (5.7 to 7.0)

Pre-Treatment vs Treatment vs Post-Treatment: p = .05, Mixed Models Analysis

Primary outcome: Stool Electrolytes During the Study Phases

Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment). Mean (95% Confidence Interval). Unit: mcg/g

Measure	Pre-Treatment n = 27	Treatment n = 24	Post-Treatment n = 24
Sodium	343 (222 to 464)	425 (288 to 562)	360 (241 to 479)
Potassium	4132 (3627 to 4637)	5923 (4796 to 7050)	4246 (3858 to 4634)
Calcium	7874 (5799 to 9948)	13017 (10448 to 15586)	7635 (5568 to 9703)
Phosphate	7719 (6630 to 8809)	7067 (5780 to 8354)	7670 (6341 to 8998)
Magnesium	1923 (1380 to 2466)	1603 (1347 to 1860)	1665 (1372 to 1958)

Pre-Treatment vs Treatment vs Post-Treatment: p = .05, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patiromer	11 of 27 (40.7%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32750456Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patiromer in people with ESRD and Hyperkalemia, run by Dominic Raj at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS) (time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.