CTRI

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CTRI Number

CTRI/2025/11/097569 [Registered on: 17/11/2025] Trial Registered Prospectively

Last Modified On:

15/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

Benefit of Liposomal iron in children with functional iron deficiency anemia in chronic kidney disease

Scientific Title of Study

Efficacy and safety of oral liposomal iron in children with functional iron deficiency anemia and chronic kidney disease

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vishnu Dev P M
Designation	Senior Resident
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI
Address	Department of Pediatrics All India Institute of Medical Sciences Ansari Nagar South DELHI 110029 India
Phone	9633642668
Fax
Email	Devvishnudr@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pankaj Hari
Designation	Professor and Head of the Department , Pediatrics
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI
Address	Room No.825, HOD office Department of Pediatrics All India Institute of Medical Sciences Ansari Nagar South DELHI 110029 India
Phone	9560701175
Fax
Email	drpankajhari@gmail.com

Details of Contact Person
Public Query

Name	Vishnu Dev P M
Designation	Senior Resident
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI
Address	Department of Pediatrics All India Institute of Medical Sciences Ansari Nagar South DELHI 110029 India
Phone	9633642668
Fax
Email	Devvishnudr@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences New Delhi

Primary Sponsor

Name	Dr Vishnu Dev P M
Address	All India Institute of Medical Sciences Ansari Nagar, New Delhi – 110029, India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vishnu Dev P M	All India Institute of Medical Sciences , New Delhi	Outpatient department and renal metabolic clinic, ward Division of Nephrology , Department of Pediatrics All India Institute of Medical Sciences Ansari Nagar, New Delhi – 110029 South DELHI	9633642668 Devvishnudr@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics Committee for Post Graduate research, AIIMS Delhi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N189\|\|Chronic kidney disease, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not Applicable	Not Applicable
Intervention	oral liposomal iron	Eligible patients will be provided with oral liposomal iron with the dose being decided as per weight band

Inclusion Criteria

Age From	3.00 Year(s)
Age To	18.00 Year(s)
Gender	Both
Details	Children with CKD stages 2 to 5 Patients in the age group of 3 years to 18 years Anemia as defined by WHO criteria Functional iron deficiency as defined by KDIGO Not receiving dialysis Erythropoiesis stimulating agent naïve or on stable dose of ESA

ExclusionCriteria

Details

Known hemoglobinopathies
Baseline hemoglobin than 7 g per dl
Known malabsorption disorders
Active infection
Kidney allograft recipients
Patients who received packed red cell transfusion or intravenous iron supplementation in last 4 weeks
Patients with parathormone levels more than 700 pg per ml
Refusal of consent

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

To determine the increase in hemoglobin levels in children aged 3 to 18 years with chronic kidney disease not on dialysis with anemia due to functional iron deficiency - transferrin saturation less than 20 percentage and serum ferritin more than 100 to 200 microgram per l who are supplemented with oral liposomal iron at a dose of 29 mg/day for children weighing less than 25 kg and 58 mg per day for more than or equal to 25 kg weight for a duration of 12 weeks
Primary Objective

12 weeks

Secondary Outcome

Outcome	TimePoints
Efficacy parameters Increase in transferrin saturation from baseline Increase in serum ferritin from baseline Change in hepcidin levels from baseline Change in reticulocyte hemoglobin equivalent and hypochromic reticulocytes	12 weeks
Safety Proportion of children with adverse events, including Serum ferritin more than 700 µg per l Gastrointestinal side effects any of these -abdominal pain, nausea, diarrhea, constipation	12 weeks

Target Sample Size

Total Sample Size="43"
Sample Size from India="43"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

25/11/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

All children with CKD stage 2 to 5, not on dialysis with anemia will be screened for functional iron deficiency, as defined by KDIGO. Patients meeting all inclusion and none of exclusion criteria will be approached for consent. If consent is provided, demographic and baseline clinical details will be noted.

All eligible patients will undergo baseline blood investigations including serum iron, serum ferritin, TIBC, Ret He, HRC. Patient will be provided sachets of liposomal iron with 29 mg elemental iron per sachet and as per the body weight (29 mg if less than 25 kg then 29 mg and 58 mg if more than or equal to 25 kg), patients will be advised to take these sachets empty stomach every day for 12 weeks. Repeat blood investigations will be done at 4, 8, and 12 weeks. All statistical analysis will be carried out at a 5% level of significance and the p value less than 0.05 will be considered as significant.