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CTRI Number  CTRI/2024/02/062336 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effectiveness and safety of oral liposomal iron and conventional iron in treating anemia in children with chronic kidney disease (stages 3–5) 
Scientific Title of Study   Efficacy and safety of oral liposomal Iron versus conventional oral Iron In children with chronic kidney disease stage 3-5 with anemia- an open labelled randomised controlled. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Kushwah 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 
Address  Ward no. 5B, Pediatric Nephrology unit Advanced Pediatric Centre (APC) Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh
CHANDIGARH
160012
India 
Phone  08285897319  
Fax    
Email  drsunilkushwah04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karalanglin Tiewsoh 
Designation  Additional Professor (Pediatric Nephrology) 
Affiliation  PGIMER, Chandigarh 
Address  Room no. 4110 Advanced Pediatric Centre (APC) Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  ktiewsoh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Sunil Kushwah 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 
Address  Ward no. 5B, Pediatric Nephrology unit Advanced Pediatric Centre (APC) Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh
CHANDIGARH
160012
India 
Phone  08285897319  
Fax    
Email  drsunilkushwah04@gmail.com  
 
Source of Monetary or Material Support  
PGIMER,Chandigarh 
 
Primary Sponsor  
Name  PGIMER, Chandigarh 
Address  PGIMER Sector 12, Chandigarh Pin code- 160012  
Type of Sponsor  Research institution and hospital 
 
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 Sunil Kushwah  Postgraduate Institute of Medical Education and Research (PGIMER)  Department of Pediatric Nephrology, Advanced pediatric centre (APC), PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 8285897319

drsunilkushwah04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institute Ethics Committee (Intramural) Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional oral iron  Children with CKD stages 3–5 who have anemia will be given oral preparation of conventional iron in the control group, and a rise in hemoglobin level will be assessed at the end of 12 weeks 
Intervention  Oral liposomal iron  Children with CKD stages 3–5 who have anemia will be given oral liposomal iron in the intervention arm, and a rise in hemoglobin level will be assessed at the end of 12 weeks. 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Age: Less than or equal to 14 years
2. Chronic kidney disease not on hemodialysis
3. Anemia based on age and gender-specific values (KDIGO 2012)
4. Normal B12 and folate levels
5. Written informed consent 
 
ExclusionCriteria 
Details  1. CKD on IV iron therapy
2. Hyperparathyroidism (iPTH >700 pg/mL)
3. Known haematological disorders
4. Bleeding or blood transfusions in the last 3 months 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Absolute increase in hemoglobin levels from baseline after 12 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of children achieving specific target hemoglobin levels (11-12 g/dL)  12 weeks 
Changes in hepcidin and low-density lipoprotein levels from baseline  12 weeks 
Percentage increase in hemoglobin level  12 weeks 
Change in iron profile (serum iron, serum transferrin, total
iron-binding capacity, ferritin, transferrin saturation) from baseline
 		 12 weeks 
Proportion of children with treatment emergent adverse events/severe adverse events  12 weeks 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/02/2024 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Children with chronic kidney disease (stages 3–5) with anemia who are not on dialysis or IV iron therapy will be enrolled in the study. 
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