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CTRI Number  CTRI/2024/08/072443 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Erythropoietin versus Desidustat for Anemia in dialysis patients 
Scientific Title of Study   Erythropoietin versus Desidustat in Anemia due to Chronic Kidney Disease with dialysis Randomized open label active control 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  Sarala N 
Designation  Professor and Head 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department of Pharmacology Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  9845750165  
Fax    
Email  saralan@sduaher.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sarala N 
Designation  Professor and Head 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department of Pharmacology Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  9845750165  
Fax    
Email  saralan@sduaher.ac.in  
 
Details of Contact Person
Public Query  
Name  Shobhana Nayak Rao 
Designation  Professor and Head 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department of Nephrology Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  9945982509  
Fax    
Email  nayak_shobhana@rediffmail.com  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Medical College Tamaka Kolar Karnataka India 563103 
 
Primary Sponsor  
Name  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Tamaka Kolar Karnataka India 563103 
Type of Sponsor  Private medical college 
 
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 Shobhana Nayak Rao  RL Jalappa Hospital and Research Centre  Department of Nephrology Room 3 Lower Ground Floor Intensive Care Unit Building
Kolar
KARNATAKA 		 9945982509

nayak_shobhana@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee Sri Devaraj Urs Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erythropoietin subcutaneous injection  Patients will receive erythropoietin 50-100units per kg per week for 24 weeks 
Intervention  Tablet Desidustat  Patients who have not received erythropoietin, their initial dose of desidustat will be 100 mg oral thrice a week and for those on erythropoietin 50-75 IU/kg once a week, the initial dose of desidustat (100 mg/125 mg/150 mg) thrice a week orally. The respective medications will be administered after dialysis on the day of dialysis. For those patients who will report twice a week for dialysis, the third dose will be administered 48 hours after the second dose. If patients’ hemoglobin goes up 1gm/dl per month, then the dose of desidustat will be reduced to 50mg thrice a week. The duration of treatment will be for 24 weeks and follow up for safety will be 2 weeks after the end of the treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients of either gender aged more than 18 years clinical diagnosis of anemia due to CKD stage 5
2.Patients on dialysis more than 2 times in a week for at least 4-6 weeks prior to screening
3.Baseline hemoglobin level of 8.0–11.0 g/dL
4.Serum ferritin more than 100ng/mL and not more than 500ng/ml and/or transferrin saturation TSAT more than 20%
5.Patients who do not have deficiency of folate or vitamin B12 after the determination of serum levels
6.Patients who had not received Erythrocyte Stimulating Agents ESA EPO analog EPO naïve for at least 4 weeks prior to screening visit and prior ESA users patients on a stable dose of ESA at least 4 weeks prior to screening
7.Patients who will be on stable dose of ESA for atleast 4 weeks prior to screening more than 30percent of dose change.
 
 
ExclusionCriteria 
Details  1. Uncontrolled hypertension SBP more than 200 mmHg or DBP more than 110 mmHg at screening visit before dialysis
2.Previous history of kidney transplant
3.Patients who have received blood transfusion within 8 weeks prior to screening
4.Patients with hepatitis B or C infection as per serology or Human immunodeficiency virus HIV infection.
5.Previous history of or currently diagnosed to have malignancy
6.Patient receiving high dose of erythropoietin at screening visit. Erythropoietin of ≥450 IU/kg/week intravenous or more than 300 IU/kg/week subcutaneous
7.Patients who have undergone major surgery in the past 3 months
8.Malabsorption syndrome, resection of the small bowel or inflammatory bowel disease
9.History of bleeding disorders
10.Stroke or intracranial hemorrhage prior to enrollment
11.Had history of allergy to Desidustat or Erythropoietin
12.Pregnant and breastfeeding women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To assess the change in the hemoglobin level between desidustat and erythropoietin in patients with chronic kidney disease (CKD) undergoing dialysis
2.To assess the adverse effects using WHO causality assessment scale
 		 Baseline and week 4 8 12 16 20 24
Week 4 12 24 26 
 
Secondary Outcome  
Outcome  TimePoints 
The number of patients with hemoglobin response  16 and 24 weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   26/08/2024 
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 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 - 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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [saralan@sduaher.ac.in].

  6. For how long will this data be available start date provided 31-08-2027 and end date provided 31-08-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

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

        Anemia is a common complication of chronic kidney disease (CKD) especially at the advanced stage of disease. The cause of anemia in CKD is due to reduced erythropoietin (EPO) secretion and several other factors, the most important being alteration in the metabolism of iron, which is due to an increase in the activity of hepcidin and reduction in the clearance.The recent trend in the management of anemia in CKD patients is by using medications that stimulate the endogenous production of erythropoietin. HIF-prolyl hydroxylase enzyme inhibitors are a new class of agents for the treatment of anemia in CKD. These agents work by stabilizing the HIF complex and stimulating endogenous erythropoietin production. Desidustat is an orally bioavailable, HIF-prolyl hydroxylase (HIF-PH) inhibitor.Furthermore HIF-PHI is an emerging oral drug for the treatment of renal anemia, there is lack of studies on its long-term efficacy and safety; like its effect on renal function and the progression of disease in patients remains unknown. The present study  will be carried out to compare the effectiveness and safety of desidustat and erythropoietin in anemia due to CKD. 

 
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