| CTRI Number |
CTRI/2023/09/058062 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An approach to intravenous Iron therapy in patients receiving dialysis regularly |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF PROACTIVE VERSUS REACTIVE APPROACH TO IV IRON THERAPY IN PATIENTS ON MAINTENANCE DIALYSIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnendu Das |
| Designation |
Resident Medicine |
| Affiliation |
Command Hospital(Eastern command) |
| Address |
Department Of Medicine,
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
8585029359 |
| Fax |
|
| Email |
krishnendudas425@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col Dr Jai Inder Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital(Eastern Command) |
| Address |
Department Of Medicine,
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
7838843391 |
| Fax |
|
| Email |
warriorjai11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnendu Das |
| Designation |
Resident Medicine |
| Affiliation |
Command Hospital(Eastern command) |
| Address |
Department Of Medicine,
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
8585029359 |
| Fax |
|
| Email |
krishnendudas425@gmail.com |
|
|
Source of Monetary or Material Support
|
| COMMAND HOSPITAL(EASTERN COMMAND),Alipore,Kolkata-700027 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Eastern Command |
| Address |
Command Hospital(Eastern Command)
Alipore Kolkata |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishnendu Das |
Command Hospital |
Department of Medicine,
Command Hospital(Eastern Command)
Alipore Kolkata- 700027
Kolkata
WEST BENGAL |
8585029359
krishnendudas425@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMAND HOSPITAL(EC) INSTUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Iron isomaltoside |
Subjects to receive Intravenous iron supplementation with iron isomaltoside (500 mg) once monthly in Proactive Group
or
0 to 1500mg once monthly as per requirement (15 mg/kg body weight) for correction of iron deficiency in reactive Group.
In Proactive (High dose) Group intravenous iron isomaltoside will be given to maintain serum ferritin level of 700mcg/l and transferrin saturation 40%
and in Reactive (Low dose) group intravenous Iron isomaltoside will be given if serum ferritin is 200mcg/l and transferrin saturation 20%. Iron Isomaltoside to be given 500mg intravenously, every month for 6 months in Proactive Group. Iron maltoside to be given in Reactive Group only if serum ferritin is below 200 mcg/l and trasferrin saturation below 20%. Dose would be 15mg/kg body weight. In case serum ferritin is more than 200 mcg/l and transferrin saturation more than 20%, no iron maltoside would be given in that month. Serum Ferritin and Transferrin saturation level will be measured in every month for 6 months. All patient will be assessed every monthly. |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
CKD patients on Maintenance dialysis (hemodialysis or peritoneal dialysis)
Age more than 18 years,
Duration of Maintenance Dialysis more than 60 days,
Hemoglobin less than 11g/dl,
Ferritin < 400 µg/l and TSAT < 30%
Follow up in Command Hospital, Eastern Command, Kolkata during study period
|
|
| ExclusionCriteria |
| Details |
Current use of IV Iron therapy or Use of IV or Oral Iron Therapy within last 15days
Blood Transfusion in last one month
Active infection (bacterial, fungal)
Known HIV or Hepatitis B or C
Known / suspected diagnosis of autoimmune disease
Past or present diagnosis of malignancy
Known diagnosis of chronic liver disease
History of any bleeding diathesis
History of gastro-intestinal surgery in past 3 months
Present or past diagnosis of peptic ulcer disease or gastro-intestinal bleeding
History of severe allergic reactions to any form of intravenous iron preparations
Pregnancy or lactation, in case of females
Life expectancy < 1 year
History of acquired iron overload
Presence of Macrocytic anemia or Low Vitamin B12 level
Patient not giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of fatigue & Quality of life index at the end of 6 months between the two groups |
At the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Major Cardiovascular Adverse Events (Non fatal stroke, Non Fatal Myocardial infarction & cardiovascular death) |
After 6 months |
| To compare the dose of Erythropoietin Stimulating agents & incidence of serious infections between the two groups |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After taking clearance from ethical committee of the institute, study will be conducted in the Department of MEDICINE, Command Hospital (EC). This will be a Randomized Clinical Trial. All eligible patients of Chronic Kidney Disease on Dialysis admitted in CHEC KOLKATA who meet the inclusion criteria will be included in the study after taking a written informed consent. Enrolment, randomization and intervention - At enrolment, subjects will enter 2 weeks run-in period. Thereafter at baseline visit, subjects shall be randomized {allocation ratio 1:1} to receive Intravenous iron supplementation with iron isomaltoside (500 mg) once monthly to Proactive Group or 0 to1500mg once monthly as per requirement (15 mg/kg body weight) for correction of iron deficiency in reactive Group. In Proactive Group intravenous iron isomaltoside given to maintain serum ferritin level of >700mcg/l and transferrin saturation > 40% and in Low dose group (Reactive Group) intravenous ferric carboxy maltose is given if serum ferritin is <200mcg/l and transferrin saturation 20%. Blood samples (whole blood, plasma & serum) would be stored for biomarker analysis at baseline visit as per case record form. Follow up visits - The subjects will be followed up monthly for 6 months after baseline visit. At these visits, Blood samples taken for Iron profile, complete blood count, renal function test, liver function test. And possible drug related side effects. In addition, information about general health and drug related side effects was sought at every months after baseline visit through telephonic interview. Subjects would be encouraged to report any change in their health status till 1 month after completion of study period. Every adverse event (major or minor) would be recorded. Blood samples (whole blood, plasma and serum) would be taken and preserved for subsequent analysis as per case record form. |