| Trial ID: | L0228 |
| Source ID: | NCT04727840
|
| Associated Drug: |
Sodium Zirconium Cyclosilicate Oral Product
|
| Title: |
Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Hyperkalemia
|
| Interventions: |
DRUG: Sodium Zirconium Cyclosilicate Oral Product
|
| Outcome Measures: |
Primary: Normalization of Serum Potassium level, Achieve a serum potassium level less than 5mEq/L, 2 days | Secondary: Change in Endothelial function, Improvement in endothelial function as measured by brachial artery ultrasound, 15 days|Change in Acidosis (serum HCO3 levels), Changes in acidosis measured by blood parameters, 15 days|Systematic inflammatory status using serum biomarkers, Changes in inflammation measured by IL-6, CRP, Soluble urokinase-type Plasminogen Activator Receptor (suPAR), Monocyte Chemoattractant Protein-1 (MCP-1), Tumor Necrosis Factor Receptor (TNF-R), Fibroblast Growth Factor 23 (FGF23), 15 days|Changes in gut microbiota using stool collections, We will perform 16S rRNA sequencing from stool samples to determine microbiota diversity and species determination., 15 days
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-15
|
| Completion Date: |
2022-01-15
|
| Results First Posted: |
|
| Last Update Posted: |
2021-02-01
|
| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04727840
|
