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CTRI Number  CTRI/2024/01/061359 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   This study aims to understand better approaches for treating anemia in patients with CKD. By doing so, it aspires to make a significant contribution to the enhancement of patient care and overall outcomes. 
Scientific Title of Study   Anemia Management in Chronic Kidney Disease: A Comparative Evaluation of HIF-PHD Inhibitor(s) and ESAs  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Pramil Tiwari 
Designation  Professor and Head 
Affiliation  National Institute of Pharmaceutical Education and Research (NIPER) Mohali 
Address  Department of Pharmacy Practice Sector 67 SAS Nagar 160062 Punjab India Room No 205

Rupnagar
PUNJAB
160062
India 
Phone  9478401174  
Fax    
Email  ptiwari@niper.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sanjay Dcruz 
Designation  Professor and Head 
Affiliation  Goverment Medical College and Hospital (GMCH) Chandigarh) 
Address  Department of General Medicine Sector 32 Chandigarh India Room No.410

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121556  
Fax    
Email  sanjaydcruz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Sanjay Dcruz 
Designation  Professor and Head 
Affiliation  Goverment Medical College and Hospital (GMCH) Chandigarh) 
Address  Department of General Medicine Sector 32 Chandigarh India Room No- 410

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121556  
Fax    
Email  sanjaydcruz@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Pharmaceutical Education and Research, Mohali 
 
Primary Sponsor  
Name  National Institute of Pharmaceutical Education and Research, Mohali 
Address  Sector 67, S.A.S. Nagar (Mohali)-160062, Punjab (India) 
Type of Sponsor  Research institution 
 
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 Sanjay DCruz  Government Medical College & Hospital (GMCH) Chandigarh  Department of General Medicine (Special Nephrology Clinic) Room No-410 Sector 32 Chandigarh 160030 India
Chandigarh
CHANDIGARH 		 9646121556

sanjaydcruz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee IEC (Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R718||Other abnormality of red blood cells,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Intervention and comparator: NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  A. All patients who are diagnosed with CKD with renal anemia & undergoing dialysis
B. Patient should have been on dialysis for at least 3 months.
C. Patients between 18-75 years will receive HIF-PHD inhibitors or ESAs
 
 
ExclusionCriteria 
Details  A. Inability to give informed consent
B. Patients unable to complete the interview
C. Psychiatric illness
D. History of malignancy
E. Any active or recent history of blood loss
F. Taking part in other drug studies
G. Pregnant and breastfeeding women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change(s) in hemoglobin from baseline to 3
rd, 6th and 12th
months.
2. Changes in the iron utilization parameters, including
serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin,
RET-He and relevant biochemistry laboratory results from
baseline.
 		 1. Change(s) in hemoglobin from baseline to 3
rd, 6th and 12th
months.
2. Changes in the iron utilization parameters, including
serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin,
RET-He and relevant biochemistry laboratory results from
baseline.
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) and serious adverse events, cardiovascular events, and hospitalization.
The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events.
To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis

To assess the HRQoL of dialysis CKD patients

CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKD 		 1 Year 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   18/01/2024 
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="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  

Chronic Kidney Disease (CKD) is a prevalent health condition worldwide, with a significant number of patients progressing to end-stage renal disease (ESRD) and requiring dialysis. Anemia is a common complication of CKD and is associated with a reduced quality of life, increased healthcare costs, and a higher risk of mortality.

Traditionally, erythropoiesis-stimulating agents (ESAs) have been the standard of care for managing anemia in CKD patients undergoing dialysis. However, emerging research has explored the potential of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitors as an alternative treatment option. This research aims to provide valuable insights into the management of anemia in CKD patients undergoing dialysis. By comparing the effectiveness, safety, cost, HRQoL, and mortality. The outcomes of the research will contribute significantly to improve the overall care and informed decision-making process for healthcare providers and policymakers, for optimal treatment approaches for the patient population.

 
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