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Clinical Trial Details

Trial ID: L1099
Source ID: NCT03326583
Associated Drug: Patiromer
Title: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03326583/results
Conditions: ESRD|Hyperkalemia|End Stage Renal Disease
Interventions: DRUG: Patiromer
Outcome Measures: Primary: 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, 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, Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)|Changes in Blood Chemistry During the Study, Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)|Stool Electrolytes During the Study Phases, Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) | Secondary: 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., 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., Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)
Sponsor/Collaborators: Sponsor: Dominic Raj
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-11-01
Completion Date: 2020-12-31
Results First Posted: 2023-03-22
Last Update Posted: 2023-05-09
Locations: DaVita K Street, Washington, District of Columbia, 20037, United States
URL: https://clinicaltrials.gov/show/NCT03326583