The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03326583|
Recruitment Status : Completed
First Posted : October 31, 2017
Results First Posted : March 22, 2023
Last Update Posted : March 22, 2023
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|ESRD Hyperkalemia End Stage Renal Disease||Drug: Patiromer||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
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.
Patiromer will be orally self-administered by participants.
- 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) ]
- 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) ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- Anticipated kidney transplant within 9 months
- Expected survival < 9 months
- Pregnancy, anticipated pregnancy, or breastfeeding
- Participation in another intervention study
- severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326583
|United States, District of Columbia|
|DaVita K Street|
|Washington, District of Columbia, United States, 20037|
Documents provided by Dominic Raj, George Washington University:
Publications of Results:
|Responsible Party:||Dominic Raj, Director of the Division of Renal Disease and Hypertension, Professor of Medicine, George Washington University|
|Other Study ID Numbers:||
|First Posted:||October 31, 2017 Key Record Dates|
|Results First Posted:||March 22, 2023|
|Last Update Posted:||March 22, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
End Stage Renal Disease
Kidney Failure, Chronic
Renal Insufficiency, Chronic