| CTRI Number |
CTRI/2025/09/093963 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of oral desidustat versus injectable eryhtropoetin in treatment of anemia in kidney disease patients |
|
Scientific Title of Study
|
Assessing the differential impact of Desidustat on Reticulocyte iron indices over traditional erythropoietin in Chronic Kidney Disease (CKD) patients irrespective of Iron status |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunn Goel |
| Designation |
MBNBS student |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Nephrology, India Institute of Medical Sciences, Bathinda
Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
7888715689 |
| Fax |
|
| Email |
gunngoel529@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Nayak |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Department of Nephrology
All India Institute of Medical Sciences, Bathinda
Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
7506150224 |
| Fax |
|
| Email |
saurabhnayak2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Nayak |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
Department of Nephrology
All India Institute of Medical Sciences, Bathinda
Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
7506150224 |
| Fax |
|
| Email |
saurabhnayak2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Gunn Goel |
| Address |
All India Institute of Medical Sciences, Bathinda-151001
Punjab |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gunn Goel |
All India Institute of Medical Sciences Bathinda |
Room no. 3102,Out Patient Clinic of Department of Nephrology,
All India Institute of Medical Sciences Bathinda,
Dabwali Road,
Bathinda,
Punjab,
India
Bathinda
PUNJAB |
7888715689
gunngoel529@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF AIIMS BATHINDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D631||Anemia in chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erythropoietin |
Erythropoietin is a recombinant form of human erythropoietin, used to increase differentiation of progenitor cells to red blood cells in the treatment of anemia.Total duration of drug given is two months. |
| Intervention |
Hypoxia Inducible Factor- Prolyl Hydroxylase Inhibitors |
Oral drug that treats anaemia in Chronic Kidney Disease by mimicking exposure to hypoxia, stimulating endogenous erythropoietin production and possibly increasing iron availability. Total duration of intervention is two months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with CKD stage 3, 4,5 (estimated Glomerular Filtration Rate below 60) with stable kidney function in past 3 months assessed by eGFR calculation with anemia (Hb less than 10 g per dL) who have given the consent to participate in the study shall be included in the study |
|
| ExclusionCriteria |
| Details |
1.Patients already on Desidustat or EPO for treatment of anaemia prior to screening
2.Patients with a history of or active bleeding
3.Post kidney allograft transplantation
4.Pregnant or expectants
5.Patients on oral or parenteral Iron therapy
6.Patients with vitamin B12, Folate deficiency
7.Patients with underlying malignancy
8.Other causes of anaemia like Hemoglobinopathies, Autoimmune haemolytic anaemia, Hypersplenism, Bone marrow disorders etc
9.Patients with HIV
10.Patients with Cirrhosis
11.ADPKD patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To detect change in reticulocyte indices from baseline after a short-term treatment with Desidustat and Standard EPO therapy.
2.To confirm role of Desidustat in mobilising iron stores. |
Monthly basis for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study differential impact of iron status on efficacy of Desidustat versus EPO therapy. |
Monthly basis for 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/09/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
All patients will undergo a screening process whereby their eligibility to be included will be assessed. The study will adhere to the tenets of the Declaration of Helsinki, and ethical clearance will be taken from the Institutional Ethics Committee. All eligible patients will be subjected to sign an informed consent prior to enrolment. Only those who agree to sign the consent form will be enrolled. Treatment naïve anaemic CKD patients will be treated as per current standards of clinical practice (KDIGO guidelines). Patients will be treated with Erythropoietin and Desidustat as per treating physician jurisdiction. Blood samples of enrolled patients will be collected at base line and on monthly basis for 2 months. Subject’s medical records will be reviewed for baseline and follow up investigations. The following investigations will be of study interest. Patients with CKD stage 3, 4,5 (estimated Glomerular Filtration Rate < 60) with stable kidney function in past 3 months assessed by eGFR calculation with anaemia (Hb less than 10 g/dL) who have given the consent to participate in the study shall be included in the study. 1.Complete blood count 2.Kidney function test 3.Liver function test 4 Serum iron 5.Total Iron Binding Capacity 6.Ferritin 7.Reticulocyte count % 8.B12 level 9.Folate level 10.Reticulocyte haemoglobin content (CHr) 11.Reticulocyte haemoglobin equivalent (Ret-He) 12.Immature reticulocyte index
|