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CTRI Number  CTRI/2023/11/059727 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 29/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Desidustat or darbepoetin to cure low blood in patients with kidney disease 
Scientific Title of Study   Assessment of the Efficacy and Safety of Desidustat vs Darbepoetin in Anemia due to chronic kidney disease: A Randomized Controlled Trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saajid Hameed 
Designation  Senior Resident (Post doctoral trainee) 
Affiliation  IGIMS, Patna 
Address  Tutor Room, Department of Pharmacology, 3rd Floor, Medical College Building, IGIMS, Sheikhpura, Patna, Bihar, India

Patna
BIHAR
800014
India 
Phone  07739929293  
Fax    
Email  saajid36@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr.) Harihar Dikshit 
Designation  President, Academic Society of Pharmacologist of IGIMS 
Affiliation  IGIMS, Patna 
Address  Department of Pharmacology, 3rd Floor, Medical College Building, IGIMS, Patna, Bihar, India

Patna
BIHAR
800014
India 
Phone  9334106381  
Fax    
Email  dikshithariharpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saajid Hameed 
Designation  Senior Resident (Post doctoral trainee) 
Affiliation  IGIMS, Patna 
Address  Tutor Room, Department of Pharmacology, 3rd Floor, Medical College Building, IGIMS, Patna, Bihar, India

Patna
BIHAR
800014
India 
Phone  07739929293  
Fax    
Email  saajid36@gmail.com  
 
Source of Monetary or Material Support  
Department of General Medicine, IGIMS, Sheikhpura, Patna, Bihar, India - 800014 
Department of Nephrology, IGIMS, Sheikhpura, Patna, Bihar, India - 800014 
 
Primary Sponsor  
Name  Saajid Hameed 
Address  Tutor Room, Department of Pharmacology, IGIMS, Sheikhpura, Patna, Bihar, India - 800014 
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 Saajid Hameed  Indira Gandhi Institute of Medical Sciences  Department of General Medicine, Sheikhpura, Patna, Bihar, India - 800014
Patna
BIHAR 		 7739929293

saajid36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna - 14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Darbepoetin Alfa  Duration of Therapy: 6 Months Darbepoetin alfa is a medication used to treat anemia due to chronic kidney disease and anemia due to chemotherapy. It is an erythropoiesis-stimulating agent (ESA) that stimulates the bone marrow to produce more red blood cells. Common side effects of Darbepoetin alfa include high blood pressure, rash, injection site pain, breathlessness, cough, peripheral edema, procedural hypotension (low blood pressure), convulsion, and thromboembolism.  
Intervention  Desidustat  Duration of Therapy: 6 Months Desidustat (Oxemiaâ„¢) is an orally bioavailable, small molecule, hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor developed by Zydus Cadila for the treatment of anaemia associated with chronic kidney disease (CKD), COVID-2019 infections and chemotherapy induced anaemia. Desidustat inhibits prolyl hydroxylase domain enzymes, resulting in the stabilisation of hypoxia-inducible factor which stimulates erythropoietin production and erythropoiesis. In March 2022, desidustat received its first approval in India for the treatment of anaemia in adults with CKD who are either on dialysis or not on dialysis. Desidustat is in clinical development in China for the treatment of anaemia in patients with CKD, in Mexico for the management of COVID-2019 infections and in the USA for the treatment of chemotherapy induced anaemia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations was to be 7.0-10.0 g/dL (both inclusive) before the enrollment.
2. Ability to understand and give informed consent for participation.
3. Male or female patients diagnosed with CKD (stage III to IV), defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
4. Male or female, 18 to 80 years of age.
5. Body weight > 40 kg.
6. Subjects not on dialysis and not expected to start dialysis during the study period.
7. Serum ferritin ≥100 ng/mL and/or TSAT >20%.
8. No iron, folate or Vitamin B12 deficiency.
 
 
ExclusionCriteria 
Details  Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
Intravenous iron within 14 days prior to enrollment.
Prior exposure of rhEPO analogues less than 04 weeks.
Red blood cell transfusion within 8 weeks prior to enrollment.
History of previous or concurrent cancer.
Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus infection.
Active infection prior to enrollment.
History of renal transplant.
Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
Presence or a history of bleeding disorders or clinical conditions that could increase risk of life-threatening bleeding.
Pregnant and breastfeeding women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in hemoglobin  0 to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Number of subjects with hemoglobin response defined as target level of 10–12 g/dL and post-treatment increase of 1 g/dL or more by Week 24  0 to 6 months 
Time to achieve target range hemoglobin level of 10–12 g/dL  Not Applicable 
Percentage of time spent in the target hemoglobin range (10-12 g/dl)  0 to 6 months 
Change in transferrin saturation  0 to 6 months 
Change in potassium levels  0 to 6 months 
Number (%) of subjects on rescue therapy  0 to 6 months 
Change in the lipid, and lipoprotein profile  0 to 6 months 
Change in blood cells count  0 to 6 months 
Change in Packed Cell Volume (PCV)  0 to 6 months 
Change in erythrocyte sedimentation rate (ESR) and C- Reactive Protein (CRP)  0 to 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/11/2023 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saajid36@gmail.com].

  6. For how long will this data be available start date provided 21-01-2025 and end date provided 31-12-2029?
    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  

Our plan is to conduct a randomized trial to assess and verify the results of phase 3 trial whether desidustat has efficacy similar to darbepoetin and whether it has acceptable risk-benefit ratio regarding its safety and tolerability. The result of this study will generate more evidence for the clinician to use this drug in pharmacotherapy of anemia due to CKD. The study result will add to current limited evidence of newly approved drug desidustat for its efficacy and safety for its use in anemia due to CKD. If acceptable risk-benefit ratio is proven, this drug can also be utilized in other causes of anemia where there is role of hepcidin in the pathophysiology of the anemia.


 
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