Trial · NCT03079869
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
NCT03079869, Phase 4, Completed, Kaiser Permanente; results first posted 2022-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients. Trials, record NCT03079869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03079869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
- NCT number
- NCT03079869
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 55 participants, actual
- Lead sponsor
- Kaiser Permanente
- Conditions
- Hyperphosphatemia
- Interventions
- Ferric Citrate
- First posted
- 2017-03-15
- Last updated
- 2022-01-13
- Results first posted
- 2022-01-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phosphorus Levels | 6 months | Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use |
| Secondary | Intravenous (IV) Iron | 6 months | The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment. |
| Secondary | Erythropoiesis Stimulating Agents (ESA) Dose | 6 months | Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome. |
| Secondary | Median Pill Count | 6 months | median pill count of ferric citrate pills/day required to maintain phosphorus control |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phosphorus Levels | 6 months | The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment | mg/dL | MEAN |
| SECONDARY | Intravenous (IV) Iron | 6 months | The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment. | mg/mo | MEAN |
| SECONDARY | Erythropoiesis Stimulating Agents (ESA) Dose | 6 months | The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and post-treatment. | units/mo | MEAN |
| SECONDARY | Median Pill Count | 6 months | The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. | tablets per day | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phosphorus Levels | Ferric Citrate - Hemodialysis | Pre-treatment | 5.3 | Standard Deviation 1 | mg/dL |
| Phosphorus Levels | Ferric Citrate - Peritoneal Dialysis | Pre-treatment | 5.6 | Standard Deviation 0.8 | mg/dL |
| Phosphorus Levels | Ferric Citrate - Hemodialysis | On-treatment | 5.4 | Standard Deviation 1.1 | mg/dL |
| Phosphorus Levels | Ferric Citrate - Peritoneal Dialysis | On-treatment | 6 | Standard Deviation 1.8 | mg/dL |
| Intravenous (IV) Iron | Ferric Citrate - Hemodialysis | Pre-Treatment | 249.2 | Standard Deviation 215.6 | mg/mo |
| Intravenous (IV) Iron | Ferric Citrate - Peritoneal Dialysis | Pre-Treatment | 21.2 | Standard Deviation 43.1 | mg/mo |
| Intravenous (IV) Iron | Ferric Citrate - Hemodialysis | On-Treatment | 102 | Standard Deviation 137.5 | mg/mo |
| Intravenous (IV) Iron | Ferric Citrate - Peritoneal Dialysis | On-Treatment | 11.6 | Standard Deviation 33.7 | mg/mo |
| Erythropoiesis Stimulating Agents (ESA) Dose | Ferric Citrate - Hemodialysis | Pre-Treatment | 28761.1 | Standard Deviation 41314.1 | units/mo |
| Erythropoiesis Stimulating Agents (ESA) Dose | Ferric Citrate - Peritoneal Dialysis | Pre-Treatment | 16724.4 | Standard Deviation 14042.3 | units/mo |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ferric Citrate - Hemodialysis | 28 | |
| Overall Study | STARTED | Ferric Citrate - Peritoneal Dialysis | 27 | |
| Overall Study | COMPLETED | Ferric Citrate - Hemodialysis | 15 | |
| Overall Study | COMPLETED | Ferric Citrate - Peritoneal Dialysis | 16 | |
| Overall Study | NOT COMPLETED | Ferric Citrate - Hemodialysis | 13 | |
| Overall Study | NOT COMPLETED | Ferric Citrate - Peritoneal Dialysis | 11 |
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 | Black stool | Gastrointestinal disorders | Ferric Citrate - Hemodialysis | 20 | 27 | |
| other | Black stool | Gastrointestinal disorders | Ferric Citrate - Peritoneal Dialysis | 25 | 27 | |
| other | Diarrhea | Gastrointestinal disorders | Ferric Citrate - Hemodialysis | 10 | 27 | |
| other | Diarrhea | Gastrointestinal disorders | Ferric Citrate - Peritoneal Dialysis | 10 | 27 | |
| other | Constipation | Gastrointestinal disorders | Ferric Citrate - Hemodialysis | 4 | 27 | |
| other | Constipation | Gastrointestinal disorders | Ferric Citrate - Peritoneal Dialysis | 5 | 27 | |
| other | Bloating/Gas | Gastrointestinal disorders | Ferric Citrate - Hemodialysis | 2 | 27 | |
| other | Bloating/Gas | Gastrointestinal disorders | Ferric Citrate - Peritoneal Dialysis | 2 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Ferric Citrate - Hemodialysis | 1 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Ferric Citrate - Peritoneal Dialysis | 2 | 27 |
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 | Ferric Citrate - Hemodialysis | 0 | 27 |
| Total, all-cause mortality | Ferric Citrate - Peritoneal Dialysis | 0 | 27 |
| Total, other adverse events | Ferric Citrate - Hemodialysis | 23 | 27 |
| Total, other adverse events | Ferric Citrate - Peritoneal Dialysis | 27 | 27 |
| Total, serious adverse events | Ferric Citrate - Hemodialysis | 7 | 27 |
| Total, serious adverse events | Ferric Citrate - Peritoneal Dialysis | 10 | 27 |
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 |
|---|---|
| Ferric Citrate - Hemodialysis vs Ferric Citrate - Peritoneal Dialysis: deaths from any cause | Trial comparisons |
| Ferric Citrate - Hemodialysis vs Ferric Citrate - Peritoneal Dialysis: 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/NCT03079869
GET https://conductscience.org/api/trials/v1/NCT03079869/events?page=2