Trial · NCT01554982

A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

NCT01554982, Phase 3, Completed, Keryx Biopharmaceuticals; results first posted 2016-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis. Trials, record NCT01554982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01554982

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
NCT number: NCT01554982
Status: Completed
Phases: Phase 3
Enrollment: 168 participants, actual
Lead sponsor: Keryx Biopharmaceuticals
Conditions: End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD
Interventions: ferric citrate
First posted: 2012-03-15
Last updated: 2016-07-13
Results first posted: 2016-07-13

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Parameters	48 Weeks	Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).
Other	Serum Phosphorus- Baseline	Baseline
Other	Serum Phosphorus- Week 48	48 weeks
Other	Ferritin- Baseline	Baseline
Other	Ferritin- Week 48	48 weeks
Other	Transferrin Saturation (TSAT) - Baseline	Baseline
Other	TSAT- Week 48	48 weeks
Other	Hemoglobin- Baseline	Baseline
Other	Hemoglobin- Week 48	48 weeks
Other	IV Iron Use	48 weeks	Percent of subjects with No IV iron intake from first dose of study drug to Week 48

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety Parameters	48 Weeks	Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency \>5%	participants	NUMBER
OTHER_PRE_SPECIFIED	Serum Phosphorus- Baseline	Baseline		mg/dL	MEAN
OTHER_PRE_SPECIFIED	Serum Phosphorus- Week 48	48 weeks		mg/dL	MEAN
OTHER_PRE_SPECIFIED	Ferritin- Baseline	Baseline		ng/mL	MEAN
OTHER_PRE_SPECIFIED	Ferritin- Week 48	48 weeks		ng/mL	MEAN
OTHER_PRE_SPECIFIED	Transferrin Saturation (TSAT) - Baseline	Baseline		percentage of saturation	MEAN
OTHER_PRE_SPECIFIED	TSAT- Week 48	48 weeks		percentage of saturation	MEAN
OTHER_PRE_SPECIFIED	Hemoglobin- Baseline	Baseline		g/dL	MEAN
OTHER_PRE_SPECIFIED	Hemoglobin- Week 48	48 weeks		g/dL	MEAN
OTHER_PRE_SPECIFIED	IV Iron Use	48 weeks		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Safety Parameters	Ferric Citrate	Subjects with at least 1 TEAE	142		participants
Safety Parameters	Ferric Citrate	Subjects with at least 1 related TEAE	35		participants
Safety Parameters	Ferric Citrate	Subjects with at least 1 serious TEAE	75		participants
Safety Parameters	Ferric Citrate	Subjects with at least 1 related, serious TEAEa	0		participants
Safety Parameters	Ferric Citrate	Total # of deaths	10		participants
Serum Phosphorus- Baseline	Ferric Citrate		5.7	Standard Deviation 1.66	mg/dL
Serum Phosphorus- Week 48	Ferric Citrate		5.2	Standard Deviation 1.34	mg/dL
Ferritin- Baseline	Ferric Citrate		709.7	Standard Deviation 385.11	ng/mL
Ferritin- Week 48	Ferric Citrate		821.0	Standard Deviation 411.54	ng/mL
Transferrin Saturation (TSAT) - Baseline	Ferric Citrate		32.4	Standard Deviation 13.51	percentage of saturation

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ferric Citrate	168
Overall Study	Received Drug	Ferric Citrate	166
Overall Study	COMPLETED	Ferric Citrate	125
Overall Study	NOT COMPLETED	Ferric Citrate	43

Source ClinicalTrials.gov

Adverse events150

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	Arteriovenous fistula site complication	Injury, poisoning and procedural complications	Ferric Citrate	12	166	17
other	Constipation	Gastrointestinal disorders	Ferric Citrate	9	166	11
other	Cough	Respiratory, thoracic and mediastinal disorders	Ferric Citrate	11	166	14
other	Diarrhoea	Gastrointestinal disorders	Ferric Citrate	26	166	29
other	Dizziness	Nervous system disorders	Ferric Citrate	9	166	13
other	Dyspnoea	Cardiac disorders	Ferric Citrate	13	166	16
other	Faeces discoloured	Gastrointestinal disorders	Ferric Citrate	14	166	14
other	Fall	Injury, poisoning and procedural complications	Ferric Citrate	9	166	14
other	Headache	Nervous system disorders	Ferric Citrate	14	166	23
other	Hypertension	Vascular disorders	Ferric Citrate	9	166	11

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ferric Citrate
Total, other adverse events	Ferric Citrate	142	166
Total, serious adverse events	Ferric Citrate	75	166

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 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.

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/NCT01554982

GET https://conductscience.org/api/trials/v1/NCT01554982/events?page=2

API reference For AI assistants