| CTRI Number |
CTRI/2025/06/088308 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess early seroconversion in accelerated Hepatitis B vaccination in advanced CKD patient. |
|
Scientific Title of Study
|
Assessment of Early Seroconversion by Accelerated Hepatitis B Vaccination in advanced CKD patients- A Randomised Control 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 |
Dr Nandhini Devi R |
| Designation |
Senior Resident |
| Affiliation |
Stanley Medical College |
| Address |
Dept of Nephrology,
Stanley Medical College,
Old Jail road, George Town,
Chennai-01.
Chennai
TAMIL NADU
600001
India |
| Phone |
|
| Fax |
|
| Email |
nandy.rajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Edwin Fernando |
| Designation |
Professor |
| Affiliation |
Stanley Medical College |
| Address |
Dept of Nephrology,
Stanley Medical College,
Old Jail road, George Town,
Chennai-01.
Chennai
TAMIL NADU
600001
India |
| Phone |
9597954598 |
| Fax |
|
| Email |
nephroeddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Edwin Fernando |
| Designation |
Professor |
| Affiliation |
Stanley Medical College |
| Address |
Dept of Nephrology,
Stanley Medical College,
Old Jail road, George Town,
Chennai-01.
Chennai
TAMIL NADU
600001
India |
| Phone |
9597954598 |
| Fax |
|
| Email |
nephroeddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Stanley Medical College, No.1, OLd jail road, George Town, Chennai, Tamil Nadu, India. Pincode-600001 |
|
|
Primary Sponsor
|
| Name |
Dr Nandhini Devi |
| Address |
Old Jail Road, George Town, Chennai - 600001. |
| Type of Sponsor |
Other [Self] |
|
|
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 Nandhini Devi |
Stanley Medical College |
Department of Nephrology, G-block, 3rd floor, Old jail road, George town, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU |
9597954598
nandy.rajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Stanley Medical College |
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 |
Hepatitis B Vaccine |
Accelerated regimen - 0,1,2,8 weeks |
| Comparator Agent |
Hepatitis B Vaccine |
Standard regimen - 0,1,2,6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years and above.
2.Patients with advanced CKD with eGFR less than 15 ml/min per 1.73m2.
3.Patients not vaccinated with Hepatitis B vaccine earlier.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of HBV infection.
2.Patients positive for HBsAg. 3.Patients positive for HIV. 4.Recent H/O intake of immunosuppressive drugs. 5.History of allergic adverse effects to other vaccines.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study was the seroconversion rate at 12 weeks after the first dose of vaccination. |
The primary outcome of the study was the seroconversion rate at 12 weeks after the first dose of vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
15/06/2025 |
| 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="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
|
The study aims to assess the early seroconversion of accelerated Hepatitis B vaccination compared to the standard vaccination regimen in patients with advanced CKD. |