| CTRI Number |
CTRI/2023/07/054621 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Desidustat VS Darbepoetin in anemia of chronic kidney disease patients undergoing maintenance haemodialysis |
|
Scientific Title of Study
|
Prolyl hydroxylase inhibitor(Desidustat) VS Erythropoiesis stimulating agent(Darbepoetin) in anemia of chronic kidney disease patients undergoing maintenance haemodialysis. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Challagulla Madhu Babu |
| Designation |
Post graduate resident |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of General medicine ,Kalinga institute of medical sciences,Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9553084064 |
| Fax |
|
| Email |
madhubabuchallagulla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pankaj Kumar Khora |
| Designation |
Associate Professor |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of General medicine ,Kalinga institute of medical sciences ,Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9178614667 |
| Fax |
|
| Email |
pankaj.khora@Kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Challagulla Madhu Babu |
| Designation |
Post graduate resident |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of General medicine ,Kalinga institute of medical sciences ,Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9553084064 |
| Fax |
|
| Email |
madhubabuchallagulla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga institute of medical sciences ,Bhubaneswar,Odisha,India. |
|
|
Primary Sponsor
|
| Name |
Kalinga institute of medical sciences |
| Address |
Department of General medicine ,Kalinga institute of medical sciences ,Bhubaneswar,Odisha. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Challagulla Madhu Babu |
Kalinga institute of medical sciences |
Department of General medicine ,Kalinga institute of medical sciences ,Bhubaneswar.
Khordha
ORISSA |
9553084064
madhubabuchallagulla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE,KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Maintenance Haemodialysis Patients with Hb8-11 g/dl in chronic kidney disease. |
|
| ExclusionCriteria |
| Details |
Patient with iron deficiency anemia .
History of Bleeding disorders.
Red blood cell transfusion within 8 weeks prior to enrollment.
History of previous or concurrent cancer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients reaching target haemoglobin(Hb g/dl) who are receiving desidustat. |
follow up at 4weeks 8weeks
& 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Saftey of desidustat.
|
follow up at 4weeks 8weeks 12 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/07/2023 |
| 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="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Erythropoiesis stimulating agents are currently the mainstay of treatment of anemia in chronic kidney disease .New approach in treatment of anemia in chronic kidney disease patients is the use of agents that stimulate endogenous erythropoietin production.Desidustat(Prolylhydroxylase inhibitor ) stimulate endogenous erythropoietin production. Primary objective:To determine the effectiveness of prolyl hydroxylase inhibitor(Desidustat) in increasing haemoglobin levels in patients with anemia of chronic kidney disease undergoing maintenance haemodialysis. Secondary objective:1.Comparing efficacy with darbepoetin 2.Comparision of safety with that of darbepoetin. |