| CTRI Number |
CTRI/2018/09/015767 [Registered on: 19/09/2018] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
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| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Bioequivalence study of Mylan’s Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) with American Regent INC’s INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50mg/mL]) in adult male and female patients with iron deficiency anemia. |
|
Scientific Title of Study
|
A multicenter, randomized, single-dose, parallel, two-treatment, bioequivalence study of Mylan’s Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) with American Regent INC’s INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50mg/mL]) following a single intravenous dose of 750mg in adult male and female patients with iron deficiency anemia |
| Trial Acronym |
IDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR148-16 Version 1 amendment 01 dated 10 August 2018 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
AXIS Clinicals Limited |
| Address |
1 121 1 Miyapur
Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500049
India |
| Phone |
8886221089 |
| Fax |
40408060 |
| Email |
subhra.l@axisclinicals.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna C Ganapathi |
| Designation |
General Manager Global Clinical R and D |
| Affiliation |
Mylan Laboratories Limited |
| Address |
9th Floor Prestige Platina Block 3 Kadubeesanalli Village Varthur Hobli Outer ring road
Bangalore Karnataka
Bangalore
KARNATAKA
560103
India |
| Phone |
9148448200 |
| Fax |
|
| Email |
PrasannaC.Ganapathi@mylan.in |
|
Details of Contact Person
Public Query
|
| Name |
Francis Micheal |
| Designation |
Associate Director |
| Affiliation |
Mylan Laboratories Limited |
| Address |
9th Floor prestige Platina Block 3 kaadubeesanalli village varthur Hobli Outer ring road
Bangalore karnataka
Bangalore
KARNATAKA
560103
India |
| Phone |
9740119700 |
| Fax |
|
| Email |
francis.micheal@mylan.com |
|
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Source of Monetary or Material Support
|
| Mylan laboratories Limited Bilekhalli Bennerghatta Road Bengaluru 560076 Karnataka |
|
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Primary Sponsor
|
| Name |
Mylan Laboratories Limited |
| Address |
Bilekahalli Bannerghatta Road
Bengaluru 560 076 karnataka
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naushad Ali |
ACSR Government Medical College |
GNT Road Nellore 524004
Nellore
ANDHRA PRADESH |
9494828694
projectspcr@gmail.com |
| Dr Deepak Diwan |
Ajanta Research Centre |
Ajanta Hospital and IVF centre 765 ABC Complex Kanpur Road Alambagh Lucknow 26005
Lucknow
UTTAR PRADESH |
9936507362
drdeepakdewan@rediffmail.com |
| Dr Vandana Baraskar |
Baraskar Hospital and Research Centre |
276 Crystal Plaza Central Bazar Road Ramdaspeth Nagpur 440010
Nagpur
MAHARASHTRA |
9423687501
jpcancercare@gmail.com |
| Dr Kuntal Shah |
Bodyline Hospitals |
Opp Annapurna Hall Near Dev Status New Vikas Gruh Road Paldi Ahmedabad 380007
Ahmadabad
GUJARAT |
8980075065
kgshah.2008@gmail.com |
| Dr Abhay Gopal Huprikar |
Grant Medical Foundation Ruby Hall Clinic |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
9822027023
abhayhuprikar@gmail.com |
| Dr Jitendra Ananad |
Kanoria Hospital and Research Centre |
Airport Gandhi Nagar Highway Village Bhat 382428
Gandhinagar
GUJARAT |
9824517101
jkanand09@gmail.com |
| Dr Raju H Badiger |
KLE s Dr Prabhakar Kore Hospital and MRC |
NH 4A Belgaum Nehru nagar Belagavi 590010
Belgaum
KARNATAKA |
83124930099
rajubadigarh@yahoo.com |
| Dr Vineet Kumar Shukla |
KRM Hospital and Research Centre |
3 92 93 Vijayant Khand Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH |
9005044010
vineetshukla38@gmail.com |
| Dr RajKumar Gautam Nikalje |
Life Point Multispeciality Hospital |
145 1 Mumbai Bangalore Highway Near Hotel Sayaji Wakad Pune 411057
Pune
MAHARASHTRA |
9028560535
Nikaljeraj80@gmail.com |
| Dr Sandeep Kumar Gupta |
M V Hospital and Research Centre |
Room 1 Ground Floor 314 30 Mirza Mandi Chowk Lucknow 26003
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Brahme Keyur Madan |
Medical College and SSG Hospital |
Department of Medicine Anandpura Vadodra 390001
Vadodara
GUJARAT |
9727729105
keyurbrahme@gmail.com |
| Dr Kasi Viswanathan Thiagarajan |
Meenakshi Mission Hospital and Research Centre |
Room 1 Fifth floor Padietric Hematology Lake Area Melur Road Madurai 625107
Madurai
TAMIL NADU |
9865481111
kasi.nair@gmail.com |
| Dr Gaurish G Gadbail |
Nirmal Hospital Private Limited |
Ring Road Surat 395002
Surat
GUJARAT |
9727712032
gaurish.g@gmail.com |
| Dr Reema Kashiva |
Noble Hospital Pvt Ltd |
153 Magarpatta City Road Hadapsar Pune 411013
Pune
MAHARASHTRA |
9922618286
reemakasiva@gmail.com |
| Dr Manjunath J |
Omega Hospital |
Mahaveer Circle kankanady Mangalore 575002
Dakshina Kannada
KARNATAKA |
7795069393
drmanjunathj.nephrology@gmail.com |
| Dr Monica Gupta |
Samvedana Hospital |
B27 88G New Colony Ravindrapuri Varanasi221005
Varanasi
UTTAR PRADESH |
05422276002
monicag@yahoo.com |
| Dr Jitendra Singh |
Sudhbhawana Hospital |
B31 80 23B Bhogabir Lanka Varansi 221005
Varanasi
UTTAR PRADESH |
7376808121
drjitengsvm@gmail.com |
| Dr Sachin Satyanarayan Soni |
United CIIGMA Institute of Medical Sciences Pvt Ltd |
Plot No 6 and 7 Survey No 10 Shahnoorwadi Dargah Road Aurangabad 431005
Aurangabad
MAHARASHTRA |
9604694115
dr_suchinsoni@yahoo.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| ACSR Ethics Committee |
Approved |
| Bodyline Hospital Ethics Committee |
Approved |
| Ethics Committee Criticare Hospital Research Instutute |
Approved |
| Ethics Committee Kodlikeri Memorial Hospital and Group of CIIGMA Hospital |
Approved |
| Institutional Ethics Committee Ajanta Hospital and IVF Centre |
Approved |
| Institutional Ethics Committee for Human Research Medical College and SSG Hospital |
Approved |
| Institutional Ethics Committee KLE university |
Approved |
| Institutional Ethics Committee M V Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre |
Approved |
| Kanoria Ethics Committee Kanoria Hospital and Research Centre |
Approved |
| KRM Hospital Ethics Committee |
Approved |
| LPR Ethics Committee |
Approved |
| Nirmal Hospital Pvt Ltd Ethics Committee |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
| Omega Ethical Committee |
Approved |
| Samvedana Hospital Ethics Committee |
Approved |
| Sudhbhawana Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) of Mylan Laboratories Limited |
The study will consist of a single period. Ferric Carboxymaltose injection 750mg/15mL [50mg/mL] with Intervention or Comparator agent in the ratio of 1:1. Single dose, one day |
| Comparator Agent |
INJECTAFER® (Ferric Carboxymaltose injection 750mg/15mL [50mg/mL]) of American Regent, INC’s. Shirley, NY 11967 |
The study will consist of a single period. Ferric Carboxymaltose injection 750mg/15mL [50mg/mL] with Intervention or Comparator agent in the ratio of 1:1. Single dose, one day. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Men or non-pregnant, non-lactating females aged 18-65 years (both inclusive)
2. Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/not appropriate or with non-dialysis dependent chronic renal disease.
3. Patients considered to be suitable for treatment with Ferric Carboxymaltose Inj. based on Investigator judgement.
4. Patients with body weight ≥ 50 kg at screening and check in, with BMI of 18.5 – 30.0 kg/m2 at the time of screening.
5. Patients with Iron status at screening defined as:
o hemoglobin of ≥ 9.0 g/dL and < 12g/dL at screening
o Ferritin levels of ≤ 100 ng/mL (or ≤ 300ng/mL when TSAT is ≤30%)
6. Patients with adequate hematopoeitic and liver function at screening
7. Female patients should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral oophorectomy; or practicing an acceptable form of birth control starting 60 days prior to dosing in case of women with a childbearing potential and prepared to continue for at least 30 days following the last treatment.
8. Patient or LAR willing to provide written informed consent to participate. Patient agrees to comply with the study procedures and requirements of the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation.
2. Patients who have received any of the following medications in recent past:
a. Parenteral iron therapy
b. Oral iron therapy
c. Erythropoiesis stimulating agents
d. Concomitant medications that may affect the PK results based on investigators discretion.
3. Patients with clinically significant or labile hypertension.
4. Patients with Stage 5 Chronic Kidney Disease (CKD)
5. Patients considered to be anemic due to other aetiology..
6. Patients with hemochromatosis or other iron storage disorders.
7. Patients with blood loss leading to hemodynamic instability.
8. Patients who had major surgery or invasive intervention within 4 weeks prior to screening, organ transplant within 6 months prior to screening, or have a surgery or intervention planned during the course of the study.
9. Patients who received whole blood transfusion or red blood cell transfusion or donated blood within 90 days prior to randomization.
10. Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
11. Patients who have HIV or positive hepatitis screen including hepatitis B surface antigen, HCV antibodies.
12. Patients with positive alcohol breath test on the day of check-in.
13. Patients who participated in another clinical trial within 60 days prior to randomization.
14. Patients with known active malignancy
15. Patients with significant comorbidities that in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the single
dose, comparative bioavailability of Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL).
|
Within 1 hr prior to dosing, 5.00 mins (after start of slow IV injection), 7.5 mins (after start of slow IV injection). At 20.00 mins, 40.00 mins, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 18.00, 24.00, 30.00, 36.00, 48.00 and 72.00 hours (after start of slow IV injection) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability as assessed by reported adverse events, laboratory and clinical investigations |
Vitals at Screening, Day -2 (check in), day0 to 3 Adverse events from screening to end of study
Laboratory tests at Screening and end of study Day 3
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="238" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2018 |
| Date of Study Completion (India) |
26/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This was a multicenter, randomized, single-dose, parallel, two-treatment, single-period, bioequivalence study. The study included screening safety assessments performed for the patients within 21 days of the Investigational Medicinal Product (IMP) administration. All eligible patients, entering into the study, were housed up to 72.00 hours post dose. After an overnight fast, as per randomization schedule, patients were administered undiluted study drug (Mylan’s Ferric Carboxymaltose Inj. or INJECTAFER®) in supine position as a slow intravenous injection using a calibrated syringe pump. Patients were checked out from the facility after the last post dose PK sample collection at 72.00 hrs and after completion of end of study procedures. Overalll, Ferric Carboxymaltose Injection 750 mg/15 mL (50 mg/ mL) was well tolerated as a single dose 750 mg/ 15 mL administered under fasting conditions.
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