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.
Trial summary
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. Read more about this study
- 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
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
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- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Dominic Raj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominic Raj, George Washington University
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