Trial · NCT03781089
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L | Week 4 | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. |
| Secondary | Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant | 4 weeks | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. |
| Secondary | Median Daily Dose of Patiromer That Was Given in Treatment Arm | Week 3 | |
| Secondary | Number of Additional Hemodialysis Treatments Due to Hyperkalemia | 4 weeks | To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia |
| Secondary | Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline | Baseline | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats). |
| Secondary | Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 | Week 4 | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats). |
| Secondary | Number of Participants Who Completed All Study Visits | 4 weeks | To determine feasibility of a large-scale hemodialysis-based trial. |
| Secondary | Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours | 4 weeks | PVCs are irregular contractions that start in the ventricles instead of the atria. |
| Secondary | Change in Serum Albumin Concentration | 4 weeks | To determine the between-group differences in serum albumin concentrations. |
| Secondary | Change in Parathyroid Hormone (PTH) Concentration | 4 weeks | To determine the between-group differences in PTH concentrations. |
| Secondary | Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued | 6 weeks | To determine the change in serum potassium concentration two weeks after study drug is discontinued |
| Secondary | Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued | 6 weeks | To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03781089/registered