Trial · NCT04622709
Registered outcomes214
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 214
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 | Baseline and study week 5 (5 weeks after study medication start | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 5 will be determined. |
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12 | Baseline and study week 12 (12 weeks after study medication start) | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 12 will be determined. |
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18 | Baseline and study week 18 (18 weeks after study medication start) | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 18 will be determined. |
| Primary | Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1 | Study week 1 (1 week after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2 | Study week 2 (2 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3 | Study week 3 (3 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4 | Study week 4 (4 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5 | Study week 5 (5 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6 | Study week 6 (6 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9 | Study week 9 (9 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13 | Study week 13 (13 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17 | Study week 17 (17 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1 | Study week 1 (1 week after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2 | Study week 2 (2 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3 | Study week 3 (3 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4 | Study week 4 (4 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5 | Study week 5 (5 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6 | Study week 6 (6 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9 | Study week 9 (9 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13 | Study week 13 (13 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined. |
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.
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