Trial · NCT03087058
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
NCT03087058, Phase 2, Terminated, Vifor Pharma, Inc.; results first posted 2022-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia. Trials, record NCT03087058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03087058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
- NCT number
- NCT03087058
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Vifor Pharma, Inc.
- Conditions
- Hyperkalemia
- Interventions
- Patiromer, Patiromer, Patiromer
- First posted
- 2017-03-22
- Last updated
- 2022-10-19
- Other registries' IDs
- eudract:2016-002785-31
- Results first posted
- 2022-09-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Potassium Levels | from Baseline to Day 14 | |
| Secondary | Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Day 14 and Week 26 | Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Serum Potassium Levels | from Baseline to Day 14 | The efficacy population includes all subjects who have taken at least 1 dose of patiromer.~As the safety population and efficacy population are the same in this study, all analyses are displayed with 1 population. | mEq/l | MEAN |
| SECONDARY | Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Day 14 and Week 26 | The efficacy population includes all subjects who have taken at least 1 dose of patiromer.~As the safety population and efficacy population are the same in this study, all analyses are displayed with 1 population. | percentage of participants (%) | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Serum Potassium Levels | Cohort 1 | -0.50 | Standard Deviation 0.542 | mEq/l | |
| Change in Serum Potassium Levels | Cohort 2 | -0.14 | Standard Deviation 0.553 | mEq/l | |
| Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Cohort 1 | Day 14 | 50.0 | 95% Confidence Interval 23.0 to 77.0 | percentage of participants (%) |
| Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Cohort 2 | Day 14 | 12.5 | 95% Confidence Interval 0.3 to 52.7 | percentage of participants (%) |
| Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Cohort 1 | Week 26 | 81.8 | 95% Confidence Interval 48.2 to 97.7 | percentage of participants (%) |
| Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L | Cohort 2 | Week 26 | 22.2 | 95% Confidence Interval 2.8 to 60.0 | percentage of participants (%) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 14 | |
| Overall Study | STARTED | Cohort 2 | 9 | |
| Overall Study | STARTED | Cohort 3 | 0 | |
| Overall Study | COMPLETED | Cohort 1 | 12 | |
| Overall Study | COMPLETED | Cohort 2 | 9 | |
| Overall Study | COMPLETED | Cohort 3 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 2 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 0 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1 | 3 | 14 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2 | 0 | 9 | 0 |
| other | Flatulence | Gastrointestinal disorders | Cohort 1 | 2 | 14 | 2 |
| other | Flatulence | Gastrointestinal disorders | Cohort 2 | 0 | 9 | 0 |
| other | Nausea | Gastrointestinal disorders | Cohort 1 | 2 | 14 | 2 |
| other | Nausea | Gastrointestinal disorders | Cohort 2 | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 0 | 9 | 0 |
| other | Constipation | Gastrointestinal disorders | Cohort 1 | 1 | 14 | 1 |
| other | Constipation | Gastrointestinal disorders | Cohort 2 | 0 | 9 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 14 |
| Total, all-cause mortality | Cohort 2 | 0 | 9 |
| Total, other adverse events | Cohort 1 | 10 | 14 |
| Total, other adverse events | Cohort 2 | 5 | 9 |
| Total, serious adverse events | Cohort 1 | 0 | 14 |
| Total, serious adverse events | Cohort 2 | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03087058
GET https://conductscience.org/api/trials/v1/NCT03087058/events?page=2