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CTRI Number  CTRI/2025/09/094517 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   A study to improve anemia treatment in kidney patients on dialysis by adjusting erythropoietin and iron doses with the help of a clinical pharmacist. 
Scientific Title of Study   Development and testing of an algorithm by a clinical pharmacist for optimization of erythropoietin and iron dosing for correcting anemia in patients undergoing hemodialysis (Proof of Concept): An Interventional Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samarth R Anigol 
Designation  M.Pharmacy (Pharmacy Practice) Postgraduate Student 
Affiliation  KLE College of Pharmacy Belagavi 
Address  Department of Pharmacy Practice Room no 15 4th Floor KLE College of Pharmacy JNMC CAMPUS Nehru Nagar Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8217541966  
Fax    
Email  anigol.sam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geetanjali S Salimath 
Designation  Associate Professor 
Affiliation  KLE College of Pharmacy Belagavi 
Address  Department of Pharmacy Practice Room no 15 4th Floor KLE College of Pharmacy JNMC CAMPUS Nehru Nagar Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9902687176  
Fax    
Email  geetanjalisalimath@klepharm.edu  
 
Details of Contact Person
Public Query  
Name  Dr Geetanjali S Salimath 
Designation  Associate Professor 
Affiliation  KLE College of Pharmacy Belagavi 
Address  Department of Pharmacy Practice Room no 15 4th Floor KLE College of Pharmacy JNMC CAMPUS Nehru Nagar Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9902687176  
Fax    
Email  geetanjalisalimath@klepharm.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  KLE College of Pharmacy Belagavi 
Address  KLE College of Pharmacy JNMC CAMPUS Nehru Nagar Belagavi Karnataka 590010 
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 Geetanjali S Salimath  KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi  Nephrology Ward Dialysis Unit Room no 28 2nd Floor Front Entrance NH Service Road, Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA 		 9902687176

geetanjalisalimath@klepharm.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLECOPBGM ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D631||Anemia in chronic kidney disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical pharmacist managed dosing of erythropoietin and iron sucrose  Patients undergoing hemodialysis will receive erythropoietin and iron sucrose according to a pharmacist-managed dosing algorithm developed in consultation with a nephrologist. The algorithm will guide dose adjustments based on hemoglobin levels and iron parameters to optimize anemia management. Dosing will be reviewed monthly and adjusted as per the algorithm for a total duration of six months. 
Comparator Agent  Standard physician-prescribed dosing of erythropoietin and iron sucrose  Patients will receive erythropoietin and iron sucrose as per usual care prescribed by their treating physician before the pharmacist-managed algorithm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Adults equal to and above 18 years of age.
2.Patients with Chronic Kidney Disease (CKD) on maintenance hemodialysis.
3.Patients diagnosed with anemia and receiving erythropoietin therapy (with or without iron supplementation).
4.Clinically stable patients able to comply with study procedures.
5.Patients who provide written informed consent.
 
 
ExclusionCriteria 
Details  1.Pregnant or lactating women.
2.Patients with active bleeding disorders or recent (within 3 months) major blood transfusion.
3.Patients with uncontrolled hypertension or severe cardiovascular instability.
4.Patients with active infection, malignancy, or other comorbidities likely to interfere with anaemia management.
5.Patients with known hypersensitivity to erythropoietin or iron preparations.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To develop and test a clinical pharmacist–managed dosing algorithm for optimizing erythropoietin and iron therapy to correct and maintain hemoglobin within the target range (10–11.5 g/dL) in patients undergoing hemodialysis.  Baseline (pre-intervention) and monthly follow-ups for 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of the pharmacist-managed algorithm on erythropoietin dose requirements compared with baseline prescribing.  Baseline, monthly follow-ups, and final assessment at 6 months. 
To assess changes in iron parameters (serum ferritin, transferrin saturation) following algorithm-based interventions.  Baseline, monthly follow-ups, and final assessment at 6 months. 
To determine the proportion of patients requiring red blood cell transfusions before and after algorithm implementation.  Baseline, monthly follow-ups, and final assessment at 6 months. 
To assess the safety of the algorithm by monitoring adverse drug reactions, iron overload, and rapid hemoglobin rises.  Baseline, monthly follow-ups, and final assessment at 6 months. 
To evaluate the acceptance rate of pharmacist recommendations by nephrologists.  Baseline, monthly follow-ups, and final assessment at 6 months. 
To assess the feasibility of implementing the dosing algorithm in a hemodialysis setting (recruitment rate, retention, time per patient review).  Baseline, monthly follow-ups, and final assessment at 6 months. 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   25/09/2025 
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="0"
Months="7"
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   This study aims to evaluate the effectiveness of a clinical pharmacist managed dosing algorithm for erythropoietin and iron sucrose therapy in patients undergoing hemodialysis. Anemia is a common complication in chronic kidney disease that can reduce quality of life and increase health risks. The study will use a structured algorithm based approach to optimize erythropoietin and iron dosing, improve hemoglobin levels, and maintain iron parameters within the recommended range. It will be conducted as a single arm prospective interventional trial with baseline monthly follow ups and a final assessment at six months. The results are expected to provide evidence for improved anemia management through pharmacist led interventions. 
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