| CTRI Number |
CTRI/2024/04/065664 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Investigator Initiated Study] |
| Study Design |
Other |
|
Public Title of Study
|
This is type of Real world, Prospective, Observational Multicenter Study to Monitor the Routine Clinical Use of Pegylated Erythropoetin (PegEPO) in the Treatment of Anemia due to Chronic Kidney Disease. |
|
Scientific Title of Study
|
A Real world, Prospective, Observational Multicenter Study to Monitor the Routine Clinical Use of Pegylated Erythropoetin (PegEPO) in the Treatment of Anemia due to Chronic Kidney Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24/002 version No. 1.0 dated Jan 24, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Srinivas |
| Designation |
Managing Director |
| Affiliation |
Dr. Sanjays Center For Kidney and Diabetes |
| Address |
357/B, Bangalore Bellary Raod, Near to HDFC Bank, Yelahanka Town, Opp. RR Gold Palace
Bangalore
KARNATAKA
560061
India |
| Phone |
9901996755 |
| Fax |
9901996755 |
| Email |
drsanjaysri872@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Srinivas |
| Designation |
Managing Director |
| Affiliation |
Dr. Sanjays Center For Kidney and Diabetes |
| Address |
357/B, Bangalore Bellary Raod, Near to HDFC Bank, Yelahanka Town, Opp. RR Gold Palace
Bangalore
KARNATAKA
560061
India |
| Phone |
9901996755 |
| Fax |
9901996755 |
| Email |
drsanjaysri872@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Srinivas |
| Designation |
Managing Director |
| Affiliation |
Dr. Sanjays Center For Kidney and Diabetes |
| Address |
357/B, Bangalore Bellary Raod, Near to HDFC Bank, Yelahanka Town, Opp. RR Gold Palace
Bangalore
KARNATAKA
560061
India |
| Phone |
9901996755 |
| Fax |
9901996755 |
| Email |
drsanjaysri872@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sanjay Srinivas, Dr. Sanjays Center For Kidney and Diabetes, Bengaluru, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr. Sanjay Srinivas |
| Address |
Dr. Sanjays Center For Kidney and Diabetes, 357/B, Bangalore Bellary Road, Near to HDFC Bank, Yelahanka Town, Opp. RR Gold Palace, Bengaluru, Karnataka- 560061 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sanjay Srinivas |
Dr. Sanjays Center For Kidney and Diabetes |
Department of Clinical Research, Room No. 357/B, Bangalore Bellary Road, Near to HDFC Bank, Yelahanka Town, Opp. RR Gold Palace, Bengaluru, Karnataka- 560061
Bangalore
KARNATAKA |
9901996755
drsanjaysri872@gmail.com |
| Dr Sanjeev Kumar A Hiremanth |
Sanjeev Clinic and Diagnostic Centre |
Department of Clinical Research, Room No. 1152, 522 Cross Road, Banashankari Stage II, Banashankari Bengaluru, Karnataka- 560070 India
Bangalore
KARNATAKA |
9844137996
sanjeevhiremanth@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. Sanjays Hospital Ethics Committee ,Dr. Sanjeev Kumar A Hiremanth |
Approved |
| Dr. Sanjays Hospital Ethics Committee, Dr. Sanjay Srinivas |
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 |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1.) Adult male or female patients, diagnosed with CKD stage IV-V (Non-Dialysis) or on Maintenance Haemodialysis (greater or equal to 3 months) and who require treatment with PegEPO will be enrolled.
(2.) Patients on rEPO/ DPO with stable dosing for 3 months.
(3.) Hb- 7 to 10g/dl.
(4.) Patients should be iron replenished and not be suffering from iron deficiency.
(5.) Patients willing to provide informed consent.
(6.) Patients receiving PegEPO as part of routine clinical practice. |
|
| ExclusionCriteria |
| Details |
(1.) Any patient who does not fit the inclusion criteria as per physicians opinion or not fit for PegEPO therapy as per PI.
(2.) Patient with a history of hypersensitivity reactions or contraindication to the excipients of Peg EPO. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To monitor the routine clinical use of PegEPO in Indian CKD patients and to assess the real-world efficacy and safety of PegEPO among Indian patients suffering from anemia due to CKD. |
Time to increase in Hb by 1gm percent from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of PegEPO in CKD patients. |
From baseline to 1 month, 3 month and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/04/2024 |
| 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="0"
Months="6"
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 real world, prospective, multicenter, observational study is being conducted to monitor the routine clinical use of PegEPO in Indian CKD patients. |