Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (NCT NCT00981045)

NCT ID: NCT00981045

Last Updated: 2018-02-20

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2561 participants

Primary outcome timeframe

Day 56

Results posted on

2018-02-20

Participant Flow

04-Sept-2009 through 15-Jun-2011; Hospitals and Medical Clinics

14 subjects randomized to FCM and 9 subjects randomized to Venofer were discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.

Participant milestones

Participant milestones
Measure	Ferric Carboxymaltose (FCM) Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg	Iron Sucrose (Venofer) Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Overall Study STARTED	1290	1294
Overall Study COMPLETED	1276	1285
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ferric Carboxymaltose (FCM) n=1276 Participants Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg	Iron Sucrose (Venofer) n=1285 Participants Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg	Total n=2561 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	468 Participants n=99 Participants	500 Participants n=107 Participants	968 Participants n=206 Participants
Age, Categorical >=65 years	808 Participants n=99 Participants	785 Participants n=107 Participants	1593 Participants n=206 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 13.00 • n=99 Participants	67.2 years STANDARD_DEVIATION 13.00 • n=107 Participants	67.3 years STANDARD_DEVIATION 12.99 • n=206 Participants
Sex: Female, Male Female	810 Participants n=99 Participants	818 Participants n=107 Participants	1628 Participants n=206 Participants
Sex: Female, Male Male	466 Participants n=99 Participants	467 Participants n=107 Participants	933 Participants n=206 Participants
Region of Enrollment United States	1276 participants n=99 Participants	1285 participants n=107 Participants	2561 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 56

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (FCM) n=1249 Participants Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg	Iron Sucrose (Venofer) n=1244 Participants Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.	1.13 g/dL Standard Deviation 1.044	0.92 g/dL Standard Deviation 0.917

PRIMARY outcome

Timeframe: Day 120

The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (FCM) n=1276 Participants Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg	Iron Sucrose (Venofer) n=1285 Participants Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.	175 participants	156 participants

Adverse Events

Ferric Carboxymaltose (FCM)

Serious events: 202 serious events

Other events: 305 other events

Deaths: 0 deaths

Iron Sucrose (Venofer)

Serious events: 197 serious events

Other events: 151 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ferric Carboxymaltose (FCM) n=1276 participants at risk Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg	Iron Sucrose (Venofer) n=1285 participants at risk Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Vascular disorders Hypertension	10.4% 133/1276 • September 4, 2009 through June 15, 2011	7.4% 95/1285 • September 4, 2009 through June 15, 2011
Gastrointestinal disorders Nausea	13.5% 172/1276 • September 4, 2009 through June 15, 2011	4.4% 56/1285 • September 4, 2009 through June 15, 2011

Additional Information

Mark A. Falone, MD

Luitpold Pharmaceuticals, Inc.

Phone: 610-650-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60