Trial · NCT01447628

IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

NCT01447628, Phase 2, Completed, Imperial College London; results first posted 2022-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients. Trials, record NCT01447628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01447628

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Trial

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

Title: IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients
NCT number: NCT01447628
Status: Completed
Phases: Phase 2
Enrollment: 56 participants, actual
Lead sponsor: Imperial College London
Conditions: Pulmonary Arterial Hypertension, Iron Deficiency
Interventions: Saline, Ferinject or CosmoFer
First posted: 2011-10-06
Last updated: 2022-03-07
Results first posted: 2022-03-07
Limitations and caveats: Refer to the detailed study description in the protocol section.

Source ClinicalTrials.gov

Registered outcomes32

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

List	Outcome	Time frame	Description
Primary	Change in Exercise Capacity - Endurance	12 Weeks post study treatment	Time measured in seconds from start to end of the endurance bicycle cardiopulmonary exercise testing at 80% of the peak work rate. Peak work rate is determined by that achieved at the baseline incremental cardiopulmonary exercise test (CPET). Note that this was the primary end-point of the European study. Endurance CPET was not done in China.
Primary	Change in Resting Pulmonary Vascular Resistance (PVR)	12 weeks post study treatment	To be measured by cardiac catheterisation in wood units.
Secondary	Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	12 weeks post study treatment	Level of VO2 at peak measured during incremental cardio-pulmonary exercise testing
Secondary	Oxygen Consumption (VO2) at Metabolic Threshold	12 weeks post study treatment	Level of VO2 at metabolic threshold measured during incremental cardio-pulmonary exercise test
Secondary	Ventilation / Volume of Exhaled Carbon Dioxide (VE/VCO2 Slope)	12 weeks post study treatment	VE/VCO2 slope measured during incremental cardio-pulmonary exercise testing
Secondary	Oxygen Consumption (VO2) / Work Rate (WR) Slope	12 weeks post study treatment	Level of VO2 / WR Slope measured during incremental cardio-pulmonary exercise testing
Secondary	Peak Oxygen (O2) Pulse Rate	12 weeks post study treatment	O2 pulse rate (amount of oxygen consumed per heart beat) at peak measured during incremental cardio-pulmonary exercise test
Secondary	Oxygen Consumption (VO2) at the End of Endurance Cardio-pulmonary Exercise Test (CPET)	12 weeks post study treatment	Level of VO2 measured at end of endurance cardio-pulmonary exercise test. Note that endurance CPET was not done in China, so this is reported only for the European dataset.
Secondary	Oxygen Consumption (VO2) at 3 Minutes	12 weeks post study treatment	Level of VO2 measured at 3 minutes into endurance cardio-pulmonary exercise test (CPET) Note that endurance CPET was not done in China, hence results are presented only for the European dataset.
Secondary	Iron Indices: Serum Iron	12 weeks post study treatment	Measurement of serum iron

1 to 10 of 32Source ClinicalTrials.gov

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Outcomes32

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Exercise Capacity - Endurance	12 Weeks post study treatment	Intention to treat (ITT)	Seconds	LEAST_SQUARES_MEAN
PRIMARY	Change in Resting Pulmonary Vascular Resistance (PVR)	12 weeks post study treatment		Wood units	MEAN
SECONDARY	Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	12 weeks post study treatment		Litres per minute	MEAN
SECONDARY	Oxygen Consumption (VO2) at Metabolic Threshold	12 weeks post study treatment		Litres per minute	MEAN
SECONDARY	Ventilation / Volume of Exhaled Carbon Dioxide (VE/VCO2 Slope)	12 weeks post study treatment		l/min/l/min	MEAN
SECONDARY	Oxygen Consumption (VO2) / Work Rate (WR) Slope	12 weeks post study treatment		ml/min/watt	MEAN
SECONDARY	Peak Oxygen (O2) Pulse Rate	12 weeks post study treatment		ml/beat	LEAST_SQUARES_MEAN
SECONDARY	Oxygen Consumption (VO2) at the End of Endurance Cardio-pulmonary Exercise Test (CPET)	12 weeks post study treatment		Litres per minute	LEAST_SQUARES_MEAN
SECONDARY	Oxygen Consumption (VO2) at 3 Minutes	12 weeks post study treatment		Litres per minute	LEAST_SQUARES_MEAN
SECONDARY	Iron Indices: Serum Iron	12 weeks post study treatment		umol/L	MEAN

1 to 10 of 32Source ClinicalTrials.gov

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Results by group94

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

Outcome	Group	Value	Spread	Units
Change in Exercise Capacity - Endurance	Ferinject Group (Europe)	315.44	95% Confidence Interval 274.68 to 356.20	Seconds
Change in Exercise Capacity - Endurance	Placebo Group (Europe)	302.89	95% Confidence Interval 260.09 to 345.69	Seconds
Change in Resting Pulmonary Vascular Resistance (PVR)	Ferinject Group (Europe)	7.69	95% Confidence Interval 5.71 to 9.17	Wood units
Change in Resting Pulmonary Vascular Resistance (PVR)	Placebo Group (Europe)	5.15	95% Confidence Interval 3.61 to 7.27	Wood units
Change in Resting Pulmonary Vascular Resistance (PVR)	Cosmofer Group (China)	11.70	95% Confidence Interval 9.16 to 14.04	Wood units
Change in Resting Pulmonary Vascular Resistance (PVR)	Placebo Group (China)	9.5	95% Confidence Interval 6.25 to 13.81	Wood units
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	Ferinject Group (Europe)	1.17	95% Confidence Interval 1.10 to 1.22	Litres per minute
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	Placebo Group (Europe)	1.13	95% Confidence Interval 1.08 to 1.21	Litres per minute
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	Cosmofer Group (China)	0.93	95% Confidence Interval 0.87 to 1.00	Litres per minute
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment	Placebo Group (China)	0.94	95% Confidence Interval 0.84 to 0.97	Litres per minute

1 to 10 of 94Source ClinicalTrials.gov

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Participant flow24

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

Period	Milestone	Group	Participants
Week 0 to Week 12 (1st Intervention)	STARTED	Ferinject Followed by Placebo (Europe)	19
Week 0 to Week 12 (1st Intervention)	STARTED	Placebo Followed by Ferinject (Europe)	20
Week 0 to Week 12 (1st Intervention)	STARTED	Cosmofer Followed by Placebo (China)	12
Week 0 to Week 12 (1st Intervention)	STARTED	Placebo Followed by Cosmofer (China)	5
Week 0 to Week 12 (1st Intervention)	COMPLETED	Ferinject Followed by Placebo (Europe)	19
Week 0 to Week 12 (1st Intervention)	COMPLETED	Placebo Followed by Ferinject (Europe)	20
Week 0 to Week 12 (1st Intervention)	COMPLETED	Cosmofer Followed by Placebo (China)	12
Week 0 to Week 12 (1st Intervention)	COMPLETED	Placebo Followed by Cosmofer (China)	4
Week 0 to Week 12 (1st Intervention)	NOT COMPLETED	Ferinject Followed by Placebo (Europe)	0
Week 0 to Week 12 (1st Intervention)	NOT COMPLETED	Placebo Followed by Ferinject (Europe)	0

1 to 10 of 24Source ClinicalTrials.gov

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Adverse events186

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	Upper Respiratory Infection	Infections and infestations	European Dataset: Iron	1	39	1
other	Upper Respiratory Infection	Infections and infestations	European Dataset: Placebo	1	39	1
other	Upper Respiratory Infection	Infections and infestations	European Dataset: Outside Window	1	39	1
other	Upper Respiratory Infection	Infections and infestations	China Dataset: Iron	1	17	1
other	Upper Respiratory Infection	Infections and infestations	China Dataset: Placebo	3	17	3
other	Upper Respiratory Infection	Infections and infestations	China Dataset: Outside Window	1	17	1
other	Flu like symptoms	General disorders	European Dataset: Iron	7	39	9
other	Flu like symptoms	General disorders	European Dataset: Placebo	5	39	6
other	Flu like symptoms	General disorders	European Dataset: Outside Window	0	39	0
other	Flu like symptoms	General disorders	China Dataset: Iron	0	17	0

1 to 10 of 186Source ClinicalTrials.gov

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Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	European Dataset: Iron	26	39
Total, all-cause mortality	European Dataset: Placebo	28	39
Total, all-cause mortality	European Dataset: Outside Window	13	39
Total, all-cause mortality	China Dataset: Iron	3	17
Total, all-cause mortality	China Dataset: Placebo	4	17
Total, all-cause mortality	China Dataset: Outside Window	2	17
Total, other adverse events	European Dataset: Iron	22	39
Total, other adverse events	European Dataset: Placebo	21	39
Total, other adverse events	European Dataset: Outside Window	11	39
Total, other adverse events	China Dataset: Iron	3	17

1 to 10 of 18Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33735594	DERIVED

Source PubMed

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/NCT01447628

GET https://conductscience.org/api/trials/v1/NCT01447628/registered?page=2

API reference For AI assistants