Trial · NCT01191255
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
NCT01191255, Phase 3, Completed, Keryx Biopharmaceuticals; results first posted 2014-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis. Trials, record NCT01191255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191255
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
- NCT number
- NCT01191255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 441 participants, actual
- Lead sponsor
- Keryx Biopharmaceuticals
- Conditions
- Hyperphosphatemia, Kidney Failure
- Interventions
- ferric citrate, ca acetate, sevelamer carbonate, placebo
- First posted
- 2010-08-30
- Last updated
- 2014-12-10
- Results first posted
- 2014-12-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | 4 weeks | Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks. |
| Secondary | Change in Mean Serum Ferritin From Baseline to Week 52 | 52 weeks | |
| Secondary | Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) | 52 weeks | |
| Secondary | IV Iron Analysis | 52 weeks | Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52) |
| Secondary | ESA Analysis | 52 weeks | Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | 4 weeks | Full Analysis Population (LOCF) | mg/dL | MEAN |
| SECONDARY | Change in Mean Serum Ferritin From Baseline to Week 52 | 52 weeks | Full Analysis Population (LOCF) | ng/mL | MEAN |
| SECONDARY | Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) | 52 weeks | Full Analysis Population (LOCF) | % Saturation | MEAN |
| SECONDARY | IV Iron Analysis | 52 weeks | mg/day | MEDIAN | |
| SECONDARY | ESA Analysis | 52 weeks | Units/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 |
|---|---|---|---|---|---|
| Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | Placebo-EAP | Baseline (Week 52) | 5.44 | Standard Deviation 1.459 | mg/dL |
| Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | KRX-0502 (Ferric Citrate)-EAP | Baseline (Week 52) | 5.12 | Standard Deviation 1.189 | mg/dL |
| Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | Placebo-EAP | End of EAP (Week 56) | 7.23 | Standard Deviation 1.784 | mg/dL |
| Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) | KRX-0502 (Ferric Citrate)-EAP | End of EAP (Week 56) | 4.89 | Standard Deviation 1.291 | mg/dL |
| Change in Mean Serum Ferritin From Baseline to Week 52 | Active Control-SAP | Baseline | 609.50 | Standard Deviation 307.689 | ng/mL |
| Change in Mean Serum Ferritin From Baseline to Week 52 | KRX-0502 (Ferric Citrate)-SAP | Baseline | 592.80 | Standard Deviation 292.863 | ng/mL |
| Change in Mean Serum Ferritin From Baseline to Week 52 | Active Control-SAP | End of SAP (Week 52) | 631.87 | Standard Deviation 368.919 | ng/mL |
| Change in Mean Serum Ferritin From Baseline to Week 52 | KRX-0502 (Ferric Citrate)-SAP | End of SAP (Week 52) | 894.88 | Standard Deviation 481.788 | ng/mL |
| Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) | Active Control-SAP | Baseline | 30.8 | Standard Deviation 11.57 | % Saturation |
| Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) | KRX-0502 (Ferric Citrate)-SAP | Baseline | 31.3 | Standard Deviation 11.21 | % Saturation |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Safety Assessment Period | STARTED | Active Control-SAP | 149 | |
| Safety Assessment Period | STARTED | KRX-0502 (Ferric Citrate)-SAP | 292 | |
| Safety Assessment Period | STARTED | Placebo-EAP | 0 | |
| Safety Assessment Period | STARTED | KRX-0502 (Ferric Citrate)-EAP | 0 | |
| Safety Assessment Period | Safety Population | Active Control-SAP | 149 | |
| Safety Assessment Period | Safety Population | KRX-0502 (Ferric Citrate)-SAP | 289 | |
| Safety Assessment Period | Safety Population | Placebo-EAP | 0 | |
| Safety Assessment Period | Safety Population | KRX-0502 (Ferric Citrate)-EAP | 0 | |
| Safety Assessment Period | COMPLETED | Active Control-SAP | 111 | |
| Safety Assessment Period | COMPLETED | KRX-0502 (Ferric Citrate)-SAP | 193 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events1,096
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 | Dyspnea | Cardiac disorders | KRX-0502 (SAP) | 10 | 289 | 10 |
| other | Dyspnea | Cardiac disorders | Active Control (SAP) | 11 | 149 | 11 |
| other | Dyspnea | Cardiac disorders | KRX-0502 (EAP) | 0 | 95 | 0 |
| other | Dyspnea | Cardiac disorders | Placebo (EAP) | 0 | 95 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | KRX-0502 (SAP) | 14 | 289 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Active Control (SAP) | 7 | 149 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | KRX-0502 (EAP) | 0 | 95 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (EAP) | 0 | 95 | 0 |
| other | Constipation | Gastrointestinal disorders | KRX-0502 (SAP) | 21 | 289 | 21 |
| other | Constipation | Gastrointestinal disorders | Active Control (SAP) | 6 | 149 | 6 |
1 to 10 of 1,096Source ClinicalTrials.gov
See all 1,096 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KRX-0502 (SAP) | ||
| Total, all-cause mortality | Active Control (SAP) | ||
| Total, all-cause mortality | KRX-0502 (EAP) | ||
| Total, all-cause mortality | Placebo (EAP) | ||
| Total, other adverse events | KRX-0502 (SAP) | 211 | 289 |
| Total, other adverse events | Active Control (SAP) | 88 | 149 |
| Total, other adverse events | KRX-0502 (EAP) | 5 | 95 |
| Total, other adverse events | Placebo (EAP) | 0 | 95 |
| Total, serious adverse events | KRX-0502 (SAP) | 114 | 289 |
| Total, serious adverse events | Active Control (SAP) | 73 | 149 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01191255
GET https://conductscience.org/api/trials/v1/NCT01191255/flow?page=2