| CTRI Number |
CTRI/2026/01/100584 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of desidustat vs darbopoeitin in the treatment of low haemoglobin levels among stages 2-4 chronic kidney disease patients attending tertiary care centres. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF PROLYL HYDROXYLASE INHIBITOR DESIDUSTAT AND DARBEPOETIN ALFA IN CHRONIC KIDNEY DISEASE PATIENTS WITH ANAEMIA IN A TERTIARY CARE CENTER. |
| 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 Nithya T |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Pharmacology, A C S Medical College and Hospital |
| Address |
A C S Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8072019437 |
| Fax |
|
| Email |
ni22081996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithya T |
| Designation |
Postgraduate Resident |
| Affiliation |
Department of Pharmacology, A C S Medical College and Hospital |
| Address |
A C S Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8072019437 |
| Fax |
|
| Email |
ni22081996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitha A |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacology, A C S MEDICAL COLLEGE AND HOSPITAL |
| Address |
A C S Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
6379364652 |
| Fax |
|
| Email |
sumithapharma@acsmch.ac.in |
|
|
Source of Monetary or Material Support
|
| A C S Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai. |
|
|
Primary Sponsor
|
| Name |
Dr Nithya T |
| Address |
C - Block, 12A10, 13 th floor, Urbanrise - COJ, Tirumazhisai, Chennai 600124 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DR NITHYA T |
ACS MEDICAL COLLEGE AND HOSPITAL |
NO-11,FIRST FLOOR,DEPARTMENT OF PHARAMACOLOGY,
VELAPANCHAVADI,CHENNAI,TAMILNADU -600077
Chennai
TAMIL NADU |
8072019437
ni22081996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGR Institute (ACS Medical College) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darbepoetin alfa |
will receive 0.45mcg/kg per week(SC) once weekly or every two weeks |
| Intervention |
Desidustat group |
will receive 100mg orally three times a week on non-consecutive days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.All stable outpatients with chronic kidney disease (CKD) stage 2–4 , not on dialysis, aged between 18-75 years ,with moderate anemia (8-10g/dl) and severe anemia (6.5-7.9 g/dl).
2.Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Recent use of erythropoiesis -stimulation agents (ESAs)
2.Recent blood transfusion within 8 weeks.
3. History of any active or recent malignancy within 5 years.
4.Pregnant or lactating.
5.History of thrombotic disorders, thromboembolism in the past.
6.Patients with iron deficiency, B12 deficiency have been ruled out
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin levels ,iron indices and RBC indices. |
Period of 12 weeks to assess the Hb, iron indicies, RBC indices level at baseline, 8th week and 12th week in both the groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving target hemoglobin. Assessment of adverse drug reaction such as alteration of liver enzymes (SGOT,SGPT )and serum electrolytes are recorded during the study.
Assessment of inflammatory biomarkers such as C-reactive protein(CRP) and erythrocyte sedimentation rate (ESR )levels and oxidative stress markers(MDA,MDO).
|
At 8th week and 12th week. |
|
|
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)
|
02/02/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
It is a prospective, randomized, open-label comparative study evaluating the efficacy and safety of Desidustat versus Darbepoetin alfa in patients with chronic kidney disease (CKD)–associated anemia at a tertiary care center.
To compare both treatments in terms of improvement and maintenance of hemoglobin levels, iron indices, and red blood cell parameters, while also assessing safety, tolerability, inflammatory markers (CRP, ESR), and oxidative stress biomarkers (MDA, MPO).
A total of 80 non-dialysis CKD patients (stage 2–4) aged 18–75 years with moderate to severe anemia will be randomized equally into two groups: one receiving oral Desidustat and the other subcutaneous Darbepoetin alfa, over a 12-week treatment period. Data will be statistically analyzed using SPSS to determine efficacy and safety outcomes.
The study is expected to provide evidence on whether Desidustat, a newer oral HIF-PH inhibitor, can serve as an effective and safe alternative to conventional erythropoiesis-stimulating agents in managing anemia in CKD patients. |