Comparative study of safety and efficacy of ferric carboxymaltose and iron sucrose in women

ISRCTN	ISRCTN14484575
DOI	https://doi.org/10.1186/ISRCTN14484575
Secondary identifying numbers	SKIMS MC/CM/IEC/15/42-50

Submission date: 12/12/2017
Registration date: 15/12/2017
Last edited: 29/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Iron deficiency anaemia (IDA) is a condition where a lack of iron in the body leads to a reduction in the number of red blood cells. The aim of this study is to assess the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in women with IDA.

Who can participate?
Women over the age of 18 with IDA

What does the study involve?
Participants are randomly allocated to receive either FCM or IS. The study lasts for six months. Participants undergo assessments at the start of the study and at weeks 2 and 4. The goals are to find out whether it is possible to achieve target levels in laboratory tests; to identify and prevent any possible drug-related problems in patients on FCM or IS; to make suggestions for the use of these drugs whenever required by evaluating the laboratory tests; to assess the time required to attain normal laboratory tests using these two drugs; and to evaluate health-related quality of life using questionnaires.

What are the possible benefits and risks of participating?
Patients receive treatment for IDA. The study's findings should help in choosing a drug treatment for IDA in women. The main risk is an adverse drug reaction to intravenous iron.

Where is the study run from?
The study is run by the University of Kashmir and takes place in Sher-i-Kashmir Institute of Medical Sciences (SKIMS) Medical College and Hospital, Bemina, Srinagar (India)

When is the study starting and how long is it expected to run for?
May 2015 to February 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Ghulam N Bader
gnbader@kashmiruniversity.ac.in
2. Amreen Naqash
anaqash.scholar@kashmiruniversity.net

Contact information

Dr Ghulam Bader
Scientific

Department of Pharmaceutical Sciences
University of Kashmir
Srinagar
190006
India

Phone	+91 (0)9419055344
Email	gnbader@kashmiruniversity.ac.in

Prof Rifat Ara
Scientific

Department of Obstetrics and Gynecology
SKIMS Medical College and Hospital
Srinagar
190017
India

Miss Amreen Naqash
Scientific

Department of Pharmaceutical Sciences
University of Kashmir
Srinagar
190006
India

Phone	+91 (0)7889776179
Email	anaqash.scholar@kashmiruniversity.net

Study information

Study design	Prospective longitudinal and interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: Phase IV clinical trials
Study objectives	To check which of the two Iron preparations, ferric carboxymaltose or iron sucrose, is better in the treatment of iron deficiency anemia.
Ethics approval(s)	Institutional Ethics Committee, Sheri-Kashmir Institute of Medical Sciences Medical College and Hospital (IEC-SKIMS MCH), 16/07/2015, ref: SKIMS MC/CM/IEC/15/42-50
Health condition(s) or problem(s) studied	Treatment of iron deficiency anemia in women with different comorbidities
Intervention	Female patients were enrolled for the study and a well-informed written consent was taken from all the patients before starting the therapy. Participants were randomly allocated in a 1:1 ratio using SNOSE to receive either ferric carboxymaltose or iron sucrose. In conformity with the standard indicators, ferric carboxymaltose and iron sucrose was given in women with iron deficiency anemia after properly evaluating the baseline demographic and clinical characteristics of the study patients. Hospital doctors and the pharmacologist were involved in choosing a dose, maintenance of the therapy and monitoring of the adverse drug reactions (ADRs). While as the administration of the drug was done by nursing staff. According to the Ganzoni’s Formula total iron required for iron repletion was calculated at baseline. The intravenous iron infusion was given according to the iron deficit calculated by and rounded up to the nearest multiple of 100 for each individual. The maximum dose of iron sucrose was 200 mg diluted in 200 ml of sterile normal saline 0.9% and given as a slow infusion over 30 minutes. The rest of the doses, as and when required, were given on alternate days following the same procedure. The maximum single dose of FCM was 1,000 mg diluted in 250 ml of sterile normal saline 0.9% given as a slow infusion over 45 minutes. If needed, rest of the doses were given on the 8th and the 15th day. In case of any adverse drug reaction (ADR), the infusion was stopped, documented, and the patient was treated for the respective ADR. The study lasted for six months. Participants also asked to complete HRQOL questionnaires and assessments at week 2 and 4.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Iron sucrose, ferric carboxymaltose
Primary outcome measure	Measured at baseline, 2 and 4 weeks: 1. The effectiveness and safety of FCM with respect to IS in achieving the target levels of laboratory biomarkers such as Hb, mean corpuscular volume (MCV), serum iron (SI), serum ferritin (SF), transferrin saturation (TS%), total iron binding capacity (TIBC) levels as prescribed under standard guidelines 2. Drug-related problems in patients on FCM or IS 3. The time required to attain normal laboratory biomarker levels
Secondary outcome measures	Health-related quality of life (HRQOL), measured using the Medical Outcomes Study Short Form 36 (SF-36) at baseline, 2 and 4 weeks
Overall study start date	01/05/2015
Completion date	25/02/2016

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Female
Target number of participants	200
Key inclusion criteria	All patients diagnosed with IDA admitted/or present for consultation in the Obstetrics and Gynecology ward of SKIMS Medical College and Hospital, Bemina, Srinagar were enrolled during the study period
Key exclusion criteria	1. Patients with uncontrolled hypertension 2. Patients with impaired renal function 3. Patients with impaired liver function 4. Patients with heart disease
Date of first enrolment	20/07/2015
Date of final enrolment	13/02/2016

Locations

Countries of recruitment

India

Study participating centre

Sher-i-Kashmir Institute of Medical Sciences Medical College and Hospital

Department of Obstetrics and Gynaecology
Bemina
Srinagar
190017
India

Sponsor information

University of Kashmir
University/education

Department of Pharmaceutical Sciences
University of Kashmir
Hazratbal
Srinagar
190006
India

Website	http://pharma.uok.edu.in/Main/Default.aspx
"ROR"	https://ror.org/032xfst36

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	20/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The work has been accepted for publication in BMC Women's Health.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available as they contain personal information related to the patient that needs to kept confidential.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/01/2018		Yes	No

Editorial Notes

29/01/2019: Publication reference added.