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CTRI Number  CTRI/2024/01/061462 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   : AN EMERGING TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENT ON HEMODAILYSIS  
Scientific Title of Study   THE STUDY OF DESIDUSTAT EFFICACY VERSUS DARBEPOETIN ALFA FOR TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS ON HEMODIALYSIS  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SOHIL SHARDA 
Designation  SENIOR RESIDENT  
Affiliation  Jawaharlal Nehru Medical College, belagum 
Address  DR SOHIL SHARDA Senior Resident Department OF Nephrology OPD No 28 Dr. Prabhakar Kore Hospital & Medical Research Centre Nehru nagar

Belgaum
KARNATAKA
590010
India 
Phone  8970736360  
Fax    
Email  sohilsharda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SOHIL SHARDA 
Designation  SENIOR RESIDENT  
Affiliation  Jawaharlal Nehru Medical College belagavi 
Address  DR SOHIL SHARDA Senior Resident Department OF Nephrology OPD No 28 Dr. Prabhakar Kore Hospital & Medical Research Centre Nehru nagar

Belgaum
KARNATAKA
590010
India 
Phone  8970736360  
Fax    
Email  sohilsharda@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RITESH RAMESH VERNEKAR 
Designation  PROFESSOR  
Affiliation  Jawaharlal Nehru Medical College , belgaum 
Address  DR RITESH RAMESH VERNEKAR Professor Opd no 28 Department of Nephrolgy Dr. Prabhakar Kore Hospital & Medical Research Centre nehru nagar

Belgaum
KARNATAKA
590010
India 
Phone  9449061633  
Fax    
Email  riteshvernekar@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre Nehru Nagar, Belagavi – 590010 Karnataka, India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
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 SOHIL SHARDA  KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Department of Nephrology OPD number 28 2nd floor
Belgaum
KARNATAKA 		 8970736360

sohilsharda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Medical College Institutional Ethical Committe  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 
Comparator Agent  Darbepoetin alfa  injection will be given once a week by sc route. This trial will be for 4 months . 
Intervention  ORAL DESIDUSTAT TABLET  Desidustat, an oral HIF-PHI(hypoxia inducible factor-prolyl hydroxylase inhibitor) for the treatment of anemia due to CKD. The initial dose of desidustat will be 100 mg thrice a week administered after dialysis on dialysis days. For those patients who reported twice a week for dialysis, the third dose will be administered 48 h after the second dose. This trial will be for 4months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Ability to understand and given informed consent for participation
2)Male or female patients diagnosed with CKD Stage V
3)Aged ≥18 years at screening visit.
4)Patients on hemodialysis (≥2 times in a week) for at least 12 weeks prior to screening visit and had access consisting of an arteriovenous fistula, AV graft, or permanent catheter).
5)Patients with no planned change in dialysis modality and with no planned renal transplant during study period
 
 
ExclusionCriteria 
Details  1)Red blood cell transfusion within 8 weeks prior to participating in the study.
2)Had history of previous or concurrent cancer.
3)Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
4)Active infection at initiation of study.
5)Had history of renal transplant.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hemoglobin level :Change in Hb levels from baseline  16 week time period 
 
Secondary Outcome  
Outcome  TimePoints 
1) Hemoglobin Response :No. of subjects with Hb response
2)Hemoglobin target range :Time to achieve target range Hb level
 		 16 week time 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/02/2024 
Date of Study Completion (India) 01/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  to contact dr sohil sharda on his email id -sohilsharda@gmail.com

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 01-04-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

·         Patient undergoing  maintenance hemodialysis in nephrology department will be screened on the basis of inclusion and exclusion criteria and will be included in the study.

·         Informed consent will be obtained 

·         Patient fulfilling the inclusion criteria and willing to participate will be included in the study 

·         The study patients will be randomly assigned in 1:1 ratio to receive either the desidustat oral tablet or the darbepoetin alfa subcutaneous injection.

·         A detailed history will be taken and basic laboratory test will be done such as cbc , renal function test , transferrin saturation  , serum iron , lipid profile , CRP  ,virals will be done .   

·         The treatment duration will be  16 weeks. Patients hemoglobin level will be checked every week during 1st month of study , followed by once in 15days for next 3 months 

·         To maintain adequate iron status, the iron supplementation (oral or parenteral) was allowed based on assessment of the iron profile (serum ferritin, serum iron, and TSAT)

·         Rescue medication (e.g., ESA and red blood cell transfusion) will be reserved for the patients whose hemoglobin level dropped below 7 g/dL or decreased by ≥2 g/dL from the baseline.




 
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