| CTRI Number |
CTRI/2025/11/096997 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An oral drug (desidustat) versus injection (erythropoietin) for decreased hemoglobin in chronic kidney disease in Jammu |
|
Scientific Title of Study
|
Desidustat versus Erythropoietin in Anaemia due to Chronic Kidney Disease A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Goyal |
| Designation |
Resident, Department of Medicine |
| Affiliation |
Government Medical College, Jammu |
| Address |
Room No 11, 5th Floor, Department of Medicine, GMC Jammu, Jammu and Kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8929884881 |
| Fax |
|
| Email |
mohitgoyal1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohit Goyal |
| Designation |
Resident, Department of Medicine |
| Affiliation |
Government Medical College, Jammu |
| Address |
Room No 11, 5th Floor, Department of Medicine, GMC Jammu, Jammu and Kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8929884881 |
| Fax |
|
| Email |
mohitgoyal1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Goyal |
| Designation |
Resident, Department of Medicine |
| Affiliation |
Government Medical College, Jammu |
| Address |
Room No 11, 5th Floor, Department of Medicine, GMC Jammu, Jammu and Kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
8929884881 |
| Fax |
|
| Email |
mohitgoyal1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Jammu, Jammu and Kashmir, India PIN 180001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College GMC Jammu India |
| Address |
Government Medical College, Jammu
Jammu and Kashmir, India
PIN 180001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit Goyal |
Government Medical College Jammu |
Room Number 10, 5th Floor, Department of Medicine, GMC Jammu
Jammu
JAMMU & KASHMIR |
8929884881
mohitgoyal1996@gmail.com |
| Dr Raju Kumar |
Government Superspeciality Hospital Jammu |
Room Number 1, 2nd Floor, Department of Nephrology, GSSH Jammu, Jammu and Kashmir (180001)
Jammu
JAMMU & KASHMIR |
8492087871
rajubhandari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Government Medical College, Jammu, Jammu and Kashmir, India (180001) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desidustat |
100–150 mg orally three times a week, dose-titrated as per protocol for 24 weeks. |
| Comparator Agent |
Erythropoietin alfa (rHuEPO) |
subcutaneous injection 50 IU/kg three times a week, titrated to target haemoglobin 10–12 g/dL do 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than 18 years with CKD stages 3–5 (including maintenance dialysis) and anaemia (Hb less than 10 g/dL), who have provided informed consent. |
|
| ExclusionCriteria |
| Details |
Active bleeding, uncontrolled hypertension, malignancy, pregnancy or lactation, recent ESA use less than 8 weeks, severe hepatic impairment, known hypersensitivity to study drugs. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in haemoglobin (g/dL) from baseline to the evaluation period (Weeks 16–24). |
Weeks 16–24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion with Hb 10–12 g/dL by Week 24 2. Time to first target Hb 10–12 g/dL 3. Change in ferritin, TSAT, lipid profile, potassium 4. Incidence of adverse events (hyperkalaemia, hypertension, vascular access thrombosis, retinopathy).
|
Weeks 16–24 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Months="8"
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
|
Anaemia is a common and disabling complication in patients with chronic kidney disease (CKD). Current treatment with injectable erythropoietin requires frequent hospital visits and may cause fluctuations in haemoglobin levels and other side effects. Desidustat is a new oral medicine that increases natural erythropoietin production by stabilising hypoxia-inducible factors and may offer a simpler alternative.
This study, named DELIGHT, is a randomised, open-label clinical trial being conducted at Government Medical College and Government Superspecialty Hospital, Jammu. Adults with CKD anaemia, both on maintenance dialysis and on medical management, will be assigned in equal numbers to receive either oral desidustat tablets or injectable erythropoietin for 24 weeks. The main aim is to compare the rise in haemoglobin between the two groups. Secondary measures include the proportion achieving target haemoglobin 10–12 g/dL, time to reach target, changes in iron and lipid parameters, and safety outcomes such as blood pressure, potassium levels, and eye or kidney findings.
Results will help determine whether oral desidustat can be an effective and convenient alternative to injectable erythropoietin for Indian patients with CKD-related anaemia.
|