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CTRI Number  CTRI/2024/12/077850 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effectiveness and safety of Desidustat tablets with another treatment (ESA) for anemia in patients with chronic kidney disease who are on peritoneal dialysis. 
Scientific Title of Study   An Open-label, Randomised, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Erythropoietin stimulating agent (ESA) for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) on Peritoneal Dialysis 
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 Indranil Ghosh 
Designation  Professor and Head, Department of Nephrology  
Affiliation  Army Hospital Research and Referral Hospital 
Address  Department of Nephrology, Army Hospital Research and Referral Hospital

New Delhi
DELHI
110010
India 
Phone  9876268895  
Fax    
Email  rajpro_5@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indranil Ghosh 
Designation  Professor and Head, Department of Nephrology  
Affiliation  Army Hospital Research and Referral Hospital 
Address  Department of Nephrology, Army Hospital Research and Referral Hospital

New Delhi
DELHI
110010
India 
Phone  9876268895  
Fax    
Email  rajpro_5@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Indranil Ghosh 
Designation  Professor and Head, Department of Nephrology  
Affiliation  Army Hospital Research and Referral Hospital 
Address  Departemtn of Nephrology, Army Hospital Research and Referral Hospital

New Delhi
DELHI
110010
India 
Phone  9876268895  
Fax    
Email  rajpro_5@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NA] 
 
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 Indranil Ghosh   Army Hospital Research and Referral Hospital  Department of Nephrology, Army Hospital Research and Referral Hospital, New Delhi
New Delhi
DELHI 		 9876268895

rajpro_5@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ARMY HOSPITAL (R AND R), DELHI CANTT  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  Desidustat   100 mg tablet, Orally, Thrice weekly, post dialysis. frequency of dosing dependent on Hb level of patients.  
Comparator Agent  Erythropoietin stimulating agen  Dose is calculated based on weight of patients, required dose is 0.6 mcg/kg. Frequency of dosing is dependent on Hb level of patients. Route - Subcutaneous Injection.  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  As per the protocol  
 
ExclusionCriteria 
Details  As per the protocol  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Desidustat Tablet versus Erythropoietin stimulating agent (ESA)
based on change of hemoglobin (Hb) levels (evaluation versus baseline) 		 To assess the efficacy of Desidustat Tablet versus Erythropoietin stimulating agent (ESA)
based on change of hemoglobin (Hb) levels (evaluation versus baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of treatment of Desidustat Tablet as compared Erythropoietin
stimulating agent (ESA) 		 24 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   23/12/2024 
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="2"
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  

Study Title

An Open-label, Randomised, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Erythropoietin Stimulating Agent (ESA) for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) on Peritoneal Dialysis.

Study Details

  • Type: Multi-center, Open-label, Randomised, Active-controlled, Prospective Study
  • Drugs: Desidustat and ESA
  • Site: Department of Nephrology, Army Hospital Research and Referral, New Delhi
  • Investigator: Dr. Indranil Ghosh
  • Duration: 24 Weeks
  • Indication: Anemia of CKD
  • Date of Protocol: 05-07-2024
  • Patient Population: Patients with anemia in CKD on Peritoneal dialysis
  • Number of Subjects: 90 (45 per arm)

Objectives

  • Primary Objective: Assess the efficacy of Desidustat Tablet versus ESA based on changes in hemoglobin (Hb) levels over 24 weeks.
  • Secondary Objectives: Evaluate the number of Hb responders, changes in serum hepcidin and HS-CRP levels, quality of life (SF-36), and treatment-emergent adverse drug reactions.

Inclusion Criteria

  • Age ≥ 14 years
  • Clinical diagnosis of anemia due to CKD with Hb < 11.0 g/dL
  • No folate or Vitamin B12 deficiency
  • On Peritoneal Dialysis for at least 12 weeks

Exclusion Criteria

  • Recent red blood cell transfusion
  • Uncontrolled diabetes or hypertension
  • History of cancer, severe allergies, or chronic inflammatory diseases
  • Active Hepatitis B/C or HIV infection
  • Recent major or minor surgery
  • Pregnant or breastfeeding women

Methodology

  • Design: Multi-center, Open-label, Active-controlled Prospective study
  • Randomisation: 1:1 ratio into Desidustat or ESA arms
  • Visits: Screening (Week -4), Randomisation (Week 0), Follow-ups (Weeks 4, 8, 16, 24)
  • Assessments: Vital signs, physical exams, safety and efficacy assessments, serum Hb, hepcidin, K+ levels, iron profile, AE collection, medication compliance, quality of life questionnaire

Treatment

  • Desidustat Arm: 100mg orally thrice weekly
  • ESA Arm: Darbapoietin or Inj CERA with dose adjustments based on current ESA dose

This study aims to demonstrate the noninferiority of Desidustat compared to ESA in treating anemia in CKD patients on Peritoneal dialysis

 
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