| CTRI Number |
CTRI/2018/01/011463 [Registered on: 22/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical study to evaluate the Effectiveness and Safety of AGIFER injection in comparison to VENOFER in patients with Iron deficiency anaemia. |
|
Scientific Title of Study
|
“A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug AGIFER (Iron Sucrose Injection 20 mg/ ml, 5 ml) injection in comparison to reference drug VENOFER (Iron Sucrose Injection 20 mg/ ml, 5 ml) in patients with Iron deficiency anaemia not responding to oral iron.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/VLPL/0524/74 version 01 dated 24 May 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadanand CD |
| Designation |
General Physician |
| Affiliation |
Rajalakshmi Multispeciality Hospital |
| Address |
Department of General Medicine 21/1, Lakshmipura Main Road,
Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
09895183173 |
| Fax |
|
| Email |
sadanandcd@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Agio Pharmaceuticals Ltd.
A-38 Nandjyot Industrial Estate,Kurla Andheri Road, Mumbai 400072, India.
|
|
|
Primary Sponsor
|
| Name |
Agio Pharmaceuticals Ltd |
| Address |
A-38 Nandjyot Industrial Estate, Kurla Andheri Road, Mumbai 400072, India. |
| 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadanand CD |
Rajalakshmi Multispeciality Hospital |
General medicine Department 21/1, Lakshmipura Main Road,
Vidyaranyapura
Bangalore
KARNATAKA |
09895183173
sadanandcd@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Instiutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, Patients with Iron deficiency anaemia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AGIFER (Iron Sucrose Injection 20 mg/ ml,5 ml) injection |
Modified International non-proprietary name:Elemental Iron
Pharmaceutical form: solution for injection
Dose: 5 mL (100 mg elemental iron) undiluted slow IV over 2 to 5 minutes. Alternatively, 5 mL (100 mg elemental iron) diluted in a maximum of 100 mL of 0.9% sodium chloride IV over at least 15 minutes. Repeat at consecutive hemodialysis sessions for a total maximum cumulative dose of 1000 mg. [If Dependent on dialysis of CKD patients]
OR
10 mL (200 mg elemental iron), undiluted, IV over 2 to 5 minutes administered on 5 different occasions within a 14- day period to achieve a total maximum cumulative dose of 1000 mg within the 14- day period. [If not dependent on dialysis of CKD patients]
|
| Comparator Agent |
VENOFER (Iron Sucrose Injection 20 mg/ ml, 5 ml) |
Modified International non-proprietary name: Elemental Iron
Pharmaceutical form: solution for injection
Dose: 5 mL (100 mg elemental iron) undiluted slow IV over 2 to 5 minutes. Alternatively, 5 mL (100 mg elemental iron) diluted in a maximum of 100 mL of 0.9% sodium chloride IV over at least 15 minutes. Repeat at consecutive hemodialysis sessions for a total maximum cumulative dose of 1000 mg. [If Dependent on dialysis of CKD patients]
OR
10 mL (200 mg elemental iron), undiluted, IV over 2 to 5 minutes administered on 5 different occasions within a 14- day period to achieve a total maximum cumulative dose of 1000 mg within the 14- day period. [If not dependent on dialysis of CKD patients]
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Male and female patients of age group above 18 years.
2. Those willing to give written informed consent and willing to adhere to protocol requirements.
3. Chronic kidney disease patients who are dependent or non-dependent on dialysis with iron deficiency anemia.
4. Iron deficiency anemia patients not responding to oral iron therapy (i.e. treatment refractory patients/ all patients had been unresponsive or had had poor responses to oral iron therapy (Hb increases less than 2 g/dL using 160-200 mg/day of oral ferrous sulphate over 4 weeks of treatment).
5. Iron Deficiency anemia Patients unable to tolerate oral iron therapy because of gastrointestinal side effects (ulcerative colitis, IBD).
6. Pregnant ladies with hemoglobin level 5-9 g% with diagnosed iron deficiency attending antenatal clinic (if the treating physician finds a need for parenteral iron therapy).
7. Patients with significant blood loss due to any cause and diagnosed with iron deficiency anemia.
8. Patients with normal folate and Vit B12 value. |
|
| ExclusionCriteria |
| Details |
1.Patients with known hypersensitivity to iron sucrose or any component of the formulation
2.Patients with Other causes of anemia other than iron deficiency (vitamin B12 or folate deficiency, etc.)
3.Patients with microcytic iron-overloading disorder (thalassemia, sideroblastic anemia)
4.Chronic alcohol abuse (alcohol consumption more than 20 g/day).
5.Presence of portal hypertension with esophageal varices
6. Patients who have received erythropoietin, intravenous iron therapy, or blood transfusion 4 weeks prior to screening
7.Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) more than 3 times the upper limit of normal range.
8.Patients with positive serology at the time of screening.
9.Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
10.Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent
11.Patients with body weight less than 30kg
12. Inability to fully comprehend and performstudy procedures in the Investigator opinion.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in Haemoglobin, haematocrit, Ferritin, Iron, transferrin saturation and Total Iron binding capacity.
2.Changes in Average size of RBCs (mean corpuscular volume, MCV), Average amount of haemoglobin in RBCs (mean corpuscular haemoglobin, MCH), Haemoglobin concentration (mean corpuscular haemoglobin concentration, MCHC) and Increased variation in the size of RBCs (red cell distribution width, RDW
|
Screening to End of Treatment- Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement on Changes in clinical signs and symptoms of iron deficiency anaemia from the screening to end of the treatment.
2.Incidence and rate of adverse events
|
Screening to End of Treatment- Day 56 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2018 |
| Date of Study Completion (India) |
18/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A prospective , Interventional, Randomised , Double blind, Parallel Group Comparative Clinical study to Evaluate the Efficacy and Safety of Test drug Agifer Iron sucrose Injection 20 mg/ml ,5ml in comparison with reference drug Venofer iron sucrose Injection 20mg/ml , 5ml in patients with Iron defeciency Anaemia not responding to oral iron.
Total of 50 subjects
Treatment duration : 56 days
Study design : Parallel group, Active controlled, Randomised
Both male and female should be included for the study .
To assess the efficacy and Safety of Iron sucrose injection by changes in Laboratory Investigation.
|