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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer | Drug | Patiromer will be orally self-administered by participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita K Street | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32750456 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patiromer | This arm is the 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: Patiromer will be orally self-administered by participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment |
| |||||||||||||
| Treatment |
| |||||||||||||
| Post-Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patiromer | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) |
|
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
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms.
AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patiromer | This arm is the 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment | Pt was admitted to the hospital Sunday, 11/19/17 after collapsing at a relatives house. He was diagnosed with hypoglycemia. Potassium was 5.9. Pt began study drug on 11/15/17 but did not take in hospital. Pt also had high glucose, 400. Pt doing well |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dominic Raj | George Washington Medical Faculty Associates | (202) 741-2296 | draj@mfa.gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2017 | Sep 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C568789 | patiromer |
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| 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) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Diabetes | Count of Participants | Participants |
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| Coronary Artery Disease | Count of Participants | Participants |
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| HIV | Count of Participants | Participants |
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| Heart Failure | Count of Participants | Participants |
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| Hemoglobin | Mean | Standard Deviation | g/dl |
|
| Mean Corpuscular Volume (MCV) | Mean | Standard Deviation | femtoliters |
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| Whole Blood Count (WBC) | Mean | Standard Deviation | 1000 cells/microliters |
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| Blood Urea Nitrogen | Mean | Standard Deviation | mg/dl |
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| Creatinine | Mean | Standard Deviation | mg/dl |
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| Sodium | Mean | Standard Deviation | mEq/L |
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| Potassium | Mean | Standard Deviation | mEq/L |
|
| Bicarbonate | Mean | Standard Deviation | mEq/L |
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| Calcium | Mean | Standard Deviation | mg/dL |
|
| Phosphate | Mean | Standard Deviation | mg/dL |
|
| Glucose | Mean | Standard Deviation | mg/dL |
|
| Parathyroid hormone (PTH) | Mean | Standard Deviation | pg/ml |
|
| Magnesium | Mean | Standard Deviation | mg/dL |
|
| Total Protein | Mean | Standard Deviation | g/dL |
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| Serum Albumin | Mean | Standard Deviation | g/dL |
|
| Kt/V | Mean | Standard Deviation | ratio |
|
| Dialysate potassium | Mean | Standard Deviation | mEq/L |
|
| Dialysate sodium | Mean | Standard Deviation | mEq/L |
|
| Dialysate calcium | Mean | Standard Deviation | mEq/dL |
|
| Erythropoietin dose | units 3 times weekly | Mean | Standard Deviation | UI/mL |
|
| Dialysate magnesium | Mean | Standard Deviation | mEq/L |
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| Doxercalciferol | 3 times weekly | Mean | Standard Deviation | micrograms |
|
| OG001 | Treatment | 12 week treatment phase, . 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. Patiromer: Patiromer will be orally self-administered by participants. |
| OG002 | Post-Treatment | 6 week follow up, off medication |
|
|
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| Primary | Serum Potassium Level Through 12 Weeks of Treatment | Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20 | Posted | Mean | 95% Confidence Interval | mEq/L | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) |
|
|
|
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| Primary | Changes in Blood Chemistry During the Study | Posted | Mean | 95% Confidence Interval | mg/dl | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) |
|
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|
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| Primary | Stool Electrolytes During the Study Phases | Posted | Mean | 95% Confidence Interval | mcg/g | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) |
|
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|
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| 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. | Targeted metabolomic analysis using p-cresol were not performed due to financial constraints. | Posted | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) |
|
|
| Secondary | 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. | Targeted metabolomic analyses using p-cresol were not performed due to financial constraints. | Posted | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment) |
|
|
| 0 |
| 27 |
| 11 |
| 27 |
| 0 |
| 27 |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment | Pt send to the emergency department mid dialysis with hypertensive urgency and headache. Given 20 mg IV hydralazine, which decreased BP. Pt was discharged on 2/14. |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pt presented in ED with SOB and cough, has history of asthma and seasonal allergies. Treated with steroids and albuterol. Drug not taking during hospitalization. |
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| Fever | Infections and infestations | Systematic Assessment | Pt presented in Ed post dialysis with 6 days of fever, headache, sore throat, R side neck pain. Blood test revealed methicillin-resistant staphylococcus aureus (MRSA ) infection. Ppt treated with antibiotics |
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| Hypoglcymia | Metabolism and nutrition disorders | Systematic Assessment | Pt arrived at dialysis feeling drowsy, blood sugar was 41, admitted to ED where treated with glucose and food. Glucose levels improved and patient returned to normal dialysis. |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient admitted to the hospital for shortness of breath and hyperkalemia (8.0). Pt treated with Veltessa. |
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| MRSA Infection | Infections and infestations | Systematic Assessment | Pt reported being hospitalized during the week of July 27, 2018 for MRSA. Pt reported being treated with antibiotics. |
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| Infection | Infections and infestations | Systematic Assessment | Pt admitted to hospital for arteriovenous (AV) fistula infection. Pt discharged on 10/10/18. Pt was off medication from 10/3-10/5. |
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| Dizzy and Disoriented | General disorders | Systematic Assessment | Pt had been complaining of feeling dizzy and disoriented w/o nausea. Bloodwork and MRI came back normal. Pt treated for vertigo and discharged. |
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| Nasuea | Gastrointestinal disorders | Systematic Assessment | Pt presented to ER on 11/14/19 with nausea/vomiting and shortness of breath (SOB). No findings on imagining studies. Pt dx w/ intractable vomiting w/ mild epigastric tenderness. Treated with ondansetron and metoclopramide and discharged |
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| Right Arm Collulitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Pt presented to ER@ request of dialysis unit. Pt c/o R arm swelling, pain, erythema. Treated with vancomycin and compression wrap. Discharged with antibiotics. |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Sodium |
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| Potassium |
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| Chloride |
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| Carbon Dioxide |
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| Calcium |
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| Phosphate |
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| Magnesium |
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| Calcium |
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| Phosphate |
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| Magnesium |
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