FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066867 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of desidustat in erythropoietin hyporesponsiveness among CKD patients 
Scientific Title of Study   A comparative analysis of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis a randomized 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  Kowsigan M 
Designation  PG student (M. pharm) 
Affiliation  PSG college of pharmacy 
Address  Room no 5 2nd floor Department of pharmacy practice PSG college of pharmacy Avinashi road Peelamedu Coimbatore 641004

Coimbatore
TAMIL NADU
641004
India 
Phone  8610056320  
Fax    
Email  kowsiganmani19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subadradevi J 
Designation  Assistant professor (M. pharm) 
Affiliation  PSG college of pharmacy 
Address  Room no 5 2nd floor Department of pharmacy practice PSG college of pharmacy Avinashi road Peelamedu Coimbatore 641004

Coimbatore
TAMIL NADU
641004
India 
Phone  8903476740  
Fax    
Email  subadradevij@psgpharma.ac.in  
 
Details of Contact Person
Public Query
 
Name  Arivazhagan S 
Designation  Consultant (MBBS, MD, DM) 
Affiliation  PSG hospitals 
Address  No 143 1st floor Department of nephrology PSG hospitals Avinashi road Peelamedu Coimbatore 641004

Coimbatore
TAMIL NADU
641004
India 
Phone  9487693686  
Fax    
Email  arivunephro@gmail.com  
 
Source of Monetary or Material Support  
Department of pharmacy practice PSG college of pharmacy Peelamedu Coimbatore 641004 
 
Primary Sponsor  
Name  Arivazhagan S 
Address  PSG hospitals avinasi road peelamedu coimbatore -641004 
Type of Sponsor  Other [] 
 
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 Arivazhagan  PSG hospitals  Department of nephrology Dialysis unit 2 first floor A block
Coimbatore
TAMIL NADU 
9487693686

arivunephro@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PSG institute of medical sciences and research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Desidustat as a add on therapy with erythropoietin alpha as a treatment group   The treatment protocol of desidustat was 50 mg BD for morning and night for weekly thrice an alternate days(except the day of hemodialysis)on oral route and the follow up period was 12 weeks (3 months) and the aim was evaluate the safety and efficacy of desidustat as an adjunct therapy in erythropoietin alpha as a intervention 
Comparator Agent  to compare effect of treatment group and control group  compare the safety and efficacy of desidustat with erythropoietin alpha as a treatment group and erythropoietin alpha as a control group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ESRD patients on maintenance hemodialysis with anemia (hemoglobin level below 8g/dl) and receiving erythropoietin alpha and iron injection.
 
 
ExclusionCriteria 
Details  Patient with red blood cell transfusion (within 4 weeks)
History of renal transplantation
Previous or concurrent cancer
Pregnancy and lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the hemoglobin level in hyporesponsive state
The adjunct therapy will be better when compared with control treatment
Can able to assess the safety of the treatment 
Hemoglobin
Hematocrit
The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce the number of hospital stays   Number of hospital stay
The hospital stay outcome calculated based on admission & discharge of patient (inpatient hospital days). in that days between the admission & discharge are used to identify the hospital stays 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 4 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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  

      Anemia is a consequence of chronic kidney and is linked to morbidity and mortality in both patients with and without dialysis-dependent CKD. Erythropoietin, including rHuEPO, demonstrate efficacy in elevating hemoglobin levels and decreasing the requirement for blood transfusions in individuals with CKD, consequently enhancing their quality of life. Approximately 5–10% of patients receiving ESAs experiences hyporesponsiveness that leads to higher cardiovascular morbidity and all-cause mortality in a significant number of individuals with CKD. Desidustat is a new molecule, hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia associated with CKD. Desidustat inhibits prolyl hydroxylase domain enzymes, resulting in the stabilization of hypoxia-inducible factor which stimulates erythropoietin production and erythropoiesis. Aim: To compare the efficacy of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis. Method: The patients were randomized into treatment and control group using the block randomization technique. The control group received erythropoietin alpha whereas treatment group received desidustat with erythropoietin alpha. The level of hemoglobin and hematocrit were measured during baseline and follow ups for both treatment and control group. Expected outcome Improvement in the hemoglobin level in hyporesponsive state, The adjunct therapy will be better when compared with control treatment and Can able to assess the safety of the treatment.






 
Close