| CTRI Number |
CTRI/2024/08/072458 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparing desidustat and erythropoietin in treatment of anaemia in post renal transplant patients |
|
Scientific Title of Study
|
A Comparative analysis of Desidustat vs Erythropoietin in the treatment of anaemia
in post renal transplant patients
|
| 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 Pooja Barak |
| Designation |
Senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Nephrology department,Post Graduate Institute of Medical Education and Research, Sector 12 , Chandigarh
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9971018920 |
| Fax |
|
| Email |
poojabarak95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Divyaveer |
| Designation |
Associate Professor , Department of Nephrology |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Nephrology department, Post Graduate Institute of Medical Education and Research , Chandigarh
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Barak |
| Designation |
Senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Reseach , Chandigarh , Chandigarh |
| Address |
Nephrology department,Post Graduate Institute of Medical Education and Research , Chandigarh
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9971018920 |
| Fax |
|
| Email |
poojabarak95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology PGIMER Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research , Chandigarh Sector 12 , Chandigarh PIN - 160012 |
| 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 Pooja Barak |
Post Graduate Institute of Medical Education and Research , Chandigarh |
Nephrology department ,Post Graduate Institute of Medical Education and Research , Chandigarh , Chandigarh Sector 12 PIN - 160012
Chandigarh
CHANDIGARH |
997108920
poojabarak95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
erythropoietin |
starting at dose of 10 k subcutaneously weekly .monitor haemoglobin every 2weekly for 8 weeks . |
| Intervention |
desidustat |
given at dose of 100mg thrice a week orally . monitioring haemoglobin every 2 weekly for 8 weeks . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post renal transplant patients who have haemoglobin less than 10 after three months of post transplant |
|
| ExclusionCriteria |
| Details |
1. Active bleeding
2.Diagnosed primary haematological like haemoglobinopathies,red cell aplasia, sickle cell anaemia
3.Active inflammatory disease
4. Malignancies
5.Pregnancy and lactation
6. Uncontrolled hypertension
7. Overt infection or sepsis
8.Severe cardiopulmonary disease
9.Intolerance to desidustat or eryhtropoietin
10.Known untreated proliferative diabetic retinopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in haemoglobin in desidustat vs erythropoietin groups |
Improvement in haemoglobin in desidustat vs erythropoietin groups after 2months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in iron profile parameters (Serum iron , Transferrin saturation , Total iron binding capacity )
2.Adverse events between the two groups |
Baseline & at the end of 2 months |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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 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
|
This is observational study in post renal transplant patients with anaemia . In this study we will compare efficacy of desidustat and erythropoetin used in patients of anaemia .The patient will be recruited from PGIMER Nephrology OPD and the decision to start any intervention will be taken by the PGIMER primary care nephrologist of the patient . |