| CTRI Number |
CTRI/2025/07/092038 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study of Diagnostic marker for anemia |
|
Scientific Title of Study
|
Study on Reticulocyte Hemoglobin Content (CHr) In Chronic Renal Disease Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-8081 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safia Hasan |
| Designation |
PhD scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
School of Life Sciences, Department of Biochemistry & Biotechnology, Sardar Bhagwan Singh University
Balawala. Dehradun
Jigar colony, gali no 2, Dhampur Road, Nehtaur Bijnor UP
Dehradun
UTTARANCHAL
248161
India |
| Phone |
7669379205 |
| Fax |
2686286 |
| Email |
24hasansafia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja Naudiyal |
| Designation |
Associate Professor |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
MLT Department, School of Allied Health Sciences, Chamber No. 8, Sardar Bhagwan Singh University Balawala, Dehradun
MLT Department, School of Allied Health Sciences, Chamber No. 8, Sardar Bhagwan Singh University Balawala, Dehradun
Dehradun
UTTARANCHAL
248161
India |
| Phone |
9897298627 |
| Fax |
2686286 |
| Email |
poojabamrara_2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Safia Hasan |
| Designation |
PhD scholar |
| Affiliation |
Sardar Bhagwan Singh University |
| Address |
School of Life Sciences, Department of Biochemistry & Biotechnology, Sardar Bhagwan Singh University, Balawala, Dehradun.
School of Life Sciences, Department of Biochemistry & Biotechnology, Sardar Bhagwan Singh University, Balawala, Dehradun.
Dehradun
UTTARANCHAL
248161
India |
| Phone |
7669379205 |
| Fax |
2686286 |
| Email |
24hasansafia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safia Hasan, School of Allied & Health Sciences, Saradar Bhagwan Singh University, Balawala, Dehradun, Uttarakhand, India
Pin Code; 248161 |
|
|
Primary Sponsor
|
| Name |
Safia Hasan |
| Address |
School of Allied & Health Sciences, Saradar Bhagwan Singh University, Balawala, Dehradun, Uttarakhand, India.
Pin code 248161 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Safia Hasan |
Sardar Bhagwan Singh University, Balawala |
Department of Biochemistry New Building, Room number 2, Sardar Bhagwan Singh University, Balawala, Dehradun
248161
India
Dehradun
UTTARANCHAL |
7669379205
2686286
24hasansafia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttaranchal Dental & Medical Reacher Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, (2) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Testing of Reticulocyte Hemoglobin Content For Anemia in CKD Patients |
Study Design Prospective Observational Cohort Study
Study Duration 12 Months Follow up at 0 3 6 9 and 12 months
Study Setting Multicenter Nephrology Hospital CKD Units
Objectives Evaluate CHr as an early indicator of anemia in CKD patients
Compare CHr with traditional markers Hb ferritin TSAT)
Assess CHr ability to predict anemia progression and response to therapy
Data Collection CHr, Hb, Ferritin, TSAT, eGFR
Followup Every 3 Months CHr Hb Ferritin TSAT anemia status treatment response
Primary Outcome Time to anemia development Hb Less than 13 g/dL for men Less than12 gdL for women in relation to baseline CHr levels
Secondary Outcomes Sensitivity and specificity of CHr Less than 29 pg for predicting anemia
Correlation of CHr with Hb ferritin TSAT
CHr ability to monitor iron ESA therapy response
Statistical Analysis Descriptive Mean SD and proportions
Comparative T test Mann Whitney U and Chi square
Predictive Cox proportional hazards model for time to anemia
ROC Curve for CHr threshold accuracy
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic Kidney Disease (CKD), stages 2–5
2. Hemoglobin level less than 11 gm /dl
3. Nno Dialysis Patient
|
|
| ExclusionCriteria |
| Details |
Active bleeding or recent transfusion within 3 months
Malignancy or active inflammation
Non CKD hematologic disorders
Pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to anemia development Hb Less than 13 gdL for men Less than 12 gdL for women in relation to baseline CHr levels |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes Sensitivity & specificity of CHr Less than 29 pg for predicting anemia
Correlation of CHr with Hb ferritin TSAT
CHr ability to monitor iron ESA therapy responses |
6 to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="345"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="0"
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
|
Anemia is a common complication in patients with Chronic Kidney Disease (CKD) due to reduced erythropoietin production, functional and absolute iron deficiency, and inflammation. Early detection and management of anemia are crucial in improving outcomes. Reticulocyte Hemoglobin Content (CHr) is emerging as a sensitive and reliable marker to assess iron availability for erythropoiesis and can serve as an early indicator of anemia in CKD patients. Early Detection of Iron Deficiency:
CHr reflects the hemoglobin content of newly formed reticulocytes, offering a real-time assessment of iron availability for red blood cell production. This makes it will be more responsive to changes in iron status than traditional markers like serum ferritin or transferrin saturation (TSAT). |