Trial Outcomes & Findings for Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy (NCT NCT04246021)

Results Overview

The median Hb change from baseline to week 12 per patient in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2022-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Ferric Carboxymaltose (Ferrinject) Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level. * Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion * If the needed Ferric carboxymaltose dose is \> 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion Ferric carboxymaltose (FCM): intravenous iron formulation
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ferric Carboxymaltose (Ferrinject) n=84 Participants Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level. * Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion * If the needed Ferric carboxymaltose dose is \> 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion Ferric carboxymaltose (FCM): intravenous iron formulation
Age, Categorical <=18 years	0 Participants n=84 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=84 Participants
Age, Categorical >=65 years	20 Participants n=84 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 10.6 • n=84 Participants
Sex: Female, Male Female	70 Participants n=84 Participants
Sex: Female, Male Male	14 Participants n=84 Participants
Region of Enrollment Jordan	84 participants n=84 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: median Hb change from baseline to week 12

The median Hb change from baseline to week 12 per patient in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=26 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency n=24 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia n=34 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
The Median Hb Change From Baseline to Week 12	2.35 gm/dl Interval -1.0 to 4.6	1.5 gm/dl Interval -1.0 to 3.7	0.5 gm/dl Interval -1.6 to 3.3

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Response defined as a Hb increment ⩾1.0gm/dL

Percentage of patients with Hb increment of at least 1.0 gm/dL during their participation (from baseline to week 12 per patient) in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=26 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency n=24 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia n=34 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.	21 Participants	17 Participants	12 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: count of patients achieving correction of anemia

Percentage of patients achieving correction of anemia (Hb \>11.0 gm/dL) during their participation (from baseline to week 12 per patient) in the three groups. A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=26 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency n=24 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia n=34 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)	20 Participants	17 Participants	18 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=26 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency n=24 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia n=34 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Response Rate in Relation to Baseline Iron Deficiency Status	21 Participants	17 Participants	12 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: Percentage of patients who will require blood transfusion or ESA treatment

Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL

Outcome measures

Outcome measures
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=84 Participants A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment	6 Participants	—	—

Adverse Events

Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia n=26 participants at risk Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34)	Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency n=24 participants at risk Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34)	Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia n=34 participants at risk Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34)
Investigations hypophosphatemia	65.4% 17/26 • up to 12 weeks from drug administration	25.0% 6/24 • up to 12 weeks from drug administration	47.1% 16/34 • up to 12 weeks from drug administration

Additional Information

Dr. Hikmat Abdel-Razeq

King Hussein Cancer Center

Phone: 0096265300460

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place