| CTRI Number |
CTRI/2024/09/073494 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Uncovering Metabolomic Markers for Renal Tranplant Outcomes |
|
Scientific Title of Study
|
Metabolomics Evaluation in Patients Post Renal Transplantation |
| 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 Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Prasad N |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankar.prasad@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Mohan V Bhojaraja |
Kasturba Medical College, Manipal |
Room No. 15, Department of Nephrology, Sharda Pai OPD, Kasturba Medical College, Manipal, Udupi, Karnataka, 576104
Udupi
KARNATAKA |
9902548725
mohan.vb@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z940||Kidney transplant status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above the age of 18 diagnosed with CKD are approved to receive kidney transplants and are willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients not receiving transplant at Kasturba Hospital. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in urine metabolite levels pre and post transplant |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in urine metabolite levels in pre transplant and Acute Tubular Necrosis |
4 months |
| Change in urine metabolite levels in pre transplant and Transplant Rejection |
4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/10/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study aims to investigate the potential of urine metabolomics as a non-invasive tool to predict renal transplant outcomes. Patients undergoing renal transplantation will be recruited from the nephrology department of Kasturba Medical College Hospital. Baseline urine samples will be collected one month prior to transplantation, followed by additional samples at three months post-transplant. A metabolomic analysis will be performed on these samples using the GC/MS method to identify potential biomarkers associated with graft function and patient outcomes. T |