| CTRI Number |
CTRI/2024/05/066867 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of desidustat in erythropoietin hyporesponsiveness among CKD patients |
|
Scientific Title of Study
|
A comparative analysis of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis a randomized 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 |
Kowsigan M |
| Designation |
PG student (M. pharm) |
| Affiliation |
PSG college of pharmacy |
| Address |
Room no 5
2nd floor
Department of pharmacy practice
PSG college of pharmacy
Avinashi road
Peelamedu
Coimbatore 641004
Coimbatore TAMIL NADU 641004 India |
| Phone |
8610056320 |
| Fax |
|
| Email |
kowsiganmani19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subadradevi J |
| Designation |
Assistant professor (M. pharm) |
| Affiliation |
PSG college of pharmacy |
| Address |
Room no 5
2nd floor
Department of pharmacy practice
PSG college of pharmacy
Avinashi road
Peelamedu
Coimbatore 641004
Coimbatore TAMIL NADU 641004 India |
| Phone |
8903476740 |
| Fax |
|
| Email |
subadradevij@psgpharma.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Arivazhagan S |
| Designation |
Consultant (MBBS, MD, DM) |
| Affiliation |
PSG hospitals |
| Address |
No 143
1st floor
Department of nephrology
PSG hospitals
Avinashi road
Peelamedu
Coimbatore 641004
Coimbatore TAMIL NADU 641004 India |
| Phone |
9487693686 |
| Fax |
|
| Email |
arivunephro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pharmacy practice
PSG college of pharmacy
Peelamedu
Coimbatore 641004 |
|
|
Primary Sponsor
|
| Name |
Arivazhagan S |
| Address |
PSG hospitals
avinasi road
peelamedu
coimbatore -641004 |
| Type of Sponsor |
Other [] |
|
|
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 Arivazhagan |
PSG hospitals |
Department of nephrology
Dialysis unit 2
first floor
A block
Coimbatore TAMIL NADU |
9487693686
arivunephro@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PSG institute of medical sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desidustat as a add on therapy with erythropoietin alpha as a treatment group |
The treatment protocol of desidustat was 50 mg BD for morning and night for weekly thrice an alternate days(except the day of hemodialysis)on oral route and the follow up period was 12 weeks (3 months) and the aim was evaluate the safety and efficacy of desidustat as an adjunct therapy in erythropoietin alpha as a intervention |
| Comparator Agent |
to compare effect of treatment group and control group |
compare the safety and efficacy of desidustat with erythropoietin alpha as a treatment group and erythropoietin alpha as a control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ESRD patients on maintenance hemodialysis with anemia (hemoglobin level below 8g/dl) and receiving erythropoietin alpha and iron injection.
|
|
| ExclusionCriteria |
| Details |
Patient with red blood cell transfusion (within 4 weeks)
History of renal transplantation
Previous or concurrent cancer
Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the hemoglobin level in hyporesponsive state
The adjunct therapy will be better when compared with control treatment
Can able to assess the safety of the treatment |
Hemoglobin
Hematocrit
The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the number of hospital stays |
Number of hospital stay
The hospital stay outcome calculated based on admission & discharge of patient (inpatient hospital days). in that days between the admission & discharge are used to identify the hospital stays |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2024 |
| 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 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
|
Anemia is a consequence of chronic kidney and is linked to morbidity and mortality in both patients with and without dialysis-dependent CKD. Erythropoietin, including rHuEPO, demonstrate efficacy in elevating hemoglobin levels and decreasing the requirement for blood transfusions in individuals with CKD, consequently enhancing their quality of life. Approximately 5–10% of patients receiving ESAs experiences hyporesponsiveness that leads to higher cardiovascular morbidity and all-cause mortality in a significant number of individuals with CKD. Desidustat is a new molecule, hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia associated with CKD. Desidustat inhibits prolyl hydroxylase domain enzymes, resulting in the stabilization of hypoxia-inducible factor which stimulates erythropoietin production and erythropoiesis. Aim: To compare the efficacy of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis. Method: The patients were randomized into treatment and control group using the block randomization technique. The control group received erythropoietin alpha whereas treatment group received desidustat with erythropoietin alpha. The level of hemoglobin and hematocrit were measured during baseline and follow ups for both treatment and control group. Expected outcome Improvement in the hemoglobin level in hyporesponsive state, The adjunct therapy will be better when compared with control treatment and Can able to assess the safety of the treatment.
|