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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryPhosphorus Levels6 monthsSerum 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
SecondaryIntravenous (IV) Iron6 monthsThe amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.
SecondaryErythropoiesis Stimulating Agents (ESA) Dose6 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.
SecondaryMedian Pill Count6 monthsmedian pill count of ferric citrate pills/day required to maintain phosphorus control

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPhosphorus Levels6 monthsThe 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-treatmentmg/dLMEAN
SECONDARYIntravenous (IV) Iron6 monthsThe 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/moMEAN
SECONDARYErythropoiesis Stimulating Agents (ESA) Dose6 monthsThe 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/moMEAN
SECONDARYMedian Pill Count6 monthsThe final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts.tablets per dayMEDIAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Phosphorus LevelsFerric Citrate - HemodialysisPre-treatment5.3Standard Deviation 1mg/dL
Phosphorus LevelsFerric Citrate - Peritoneal DialysisPre-treatment5.6Standard Deviation 0.8mg/dL
Phosphorus LevelsFerric Citrate - HemodialysisOn-treatment5.4Standard Deviation 1.1mg/dL
Phosphorus LevelsFerric Citrate - Peritoneal DialysisOn-treatment6Standard Deviation 1.8mg/dL
Intravenous (IV) IronFerric Citrate - HemodialysisPre-Treatment249.2Standard Deviation 215.6mg/mo
Intravenous (IV) IronFerric Citrate - Peritoneal DialysisPre-Treatment21.2Standard Deviation 43.1mg/mo
Intravenous (IV) IronFerric Citrate - HemodialysisOn-Treatment102Standard Deviation 137.5mg/mo
Intravenous (IV) IronFerric Citrate - Peritoneal DialysisOn-Treatment11.6Standard Deviation 33.7mg/mo
Erythropoiesis Stimulating Agents (ESA) DoseFerric Citrate - HemodialysisPre-Treatment28761.1Standard Deviation 41314.1units/mo
Erythropoiesis Stimulating Agents (ESA) DoseFerric Citrate - Peritoneal DialysisPre-Treatment16724.4Standard Deviation 14042.3units/mo

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDFerric Citrate - Hemodialysis28
Overall StudySTARTEDFerric Citrate - Peritoneal Dialysis27
Overall StudyCOMPLETEDFerric Citrate - Hemodialysis15
Overall StudyCOMPLETEDFerric Citrate - Peritoneal Dialysis16
Overall StudyNOT COMPLETEDFerric Citrate - Hemodialysis13
Overall StudyNOT COMPLETEDFerric Citrate - Peritoneal Dialysis11

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherBlack stoolGastrointestinal disordersFerric Citrate - Hemodialysis2027
otherBlack stoolGastrointestinal disordersFerric Citrate - Peritoneal Dialysis2527
otherDiarrheaGastrointestinal disordersFerric Citrate - Hemodialysis1027
otherDiarrheaGastrointestinal disordersFerric Citrate - Peritoneal Dialysis1027
otherConstipationGastrointestinal disordersFerric Citrate - Hemodialysis427
otherConstipationGastrointestinal disordersFerric Citrate - Peritoneal Dialysis527
otherBloating/GasGastrointestinal disordersFerric Citrate - Hemodialysis227
otherBloating/GasGastrointestinal disordersFerric Citrate - Peritoneal Dialysis227
otherAbdominal painGastrointestinal disordersFerric Citrate - Hemodialysis127
otherAbdominal painGastrointestinal disordersFerric Citrate - Peritoneal Dialysis227

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityFerric Citrate - Hemodialysis027
Total, all-cause mortalityFerric Citrate - Peritoneal Dialysis027
Total, other adverse eventsFerric Citrate - Hemodialysis2327
Total, other adverse eventsFerric Citrate - Peritoneal Dialysis2727
Total, serious adverse eventsFerric Citrate - Hemodialysis727
Total, serious adverse eventsFerric Citrate - Peritoneal Dialysis1027

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.

ComparisonSource
Ferric Citrate - Hemodialysis vs Ferric Citrate - Peritoneal Dialysis: deaths from any causeTrial comparisons
Ferric Citrate - Hemodialysis vs Ferric Citrate - Peritoneal Dialysis: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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