| CTRI Number |
CTRI/2026/01/102181 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Two Different Steroid Treatment Methods in Kidney Transplant Rejection Patients |
|
Scientific Title of Study
|
Comparison of Slow Tapering vs Maintenance Low-dose Steroid Regimens in the Management of T Cell-Mediated Rejection in Renal Transplant Recipients: Impact on Allograft Function and Urinary Biomarkers |
| 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 SANTHOSHKUMAR G |
| Designation |
Senior Resident |
| Affiliation |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research(PGIMER) |
| Address |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research,Madhya Marg,Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8667094790 |
| Fax |
|
| Email |
santhoshgnanabalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Divyaveer |
| Designation |
Associate Professor |
| Affiliation |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research(PGIMER) |
| Address |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research,Madhya Marg,Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSmita Divyaveer G |
| Designation |
Associate Professor |
| Affiliation |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research(PGIMER) |
| Address |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research,Madhya Marg,Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Departement of Nephrology,Postgraduate Institue of Medical Education and Research,Madhya Marg,Sector 12, Chandigarh-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 SANTHOSHKUMAR G |
PGIMER |
DEPARTEMENT OF NEPHROLOGY PGIMER.MADHYA MARG SECTOR 12 CHANDIGARH 160012
Chandigarh
CHANDIGARH |
8667094790
santhoshgnanabalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institue of medical Education and Research , chandigarh Institutional Ethics Committe ( intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low-Dose Maintenance |
Patients will receive pulse therapy, followed by resumption of their pre-rejection oral prednisone maintenance dose . No tapering will be performed in this group |
| Intervention |
slow tapering steroid Regimen |
Patients will receive standard pulse therapy followed by oral prednisone at a dose of 0.5 mg per kg per day (approximately 30 mg per day for a 60 kg patient). The dose will be tapered by 5 mg per week to reach a maintenance dose of 5 mg per day, which will be continued thereafter. The tapering duration will range from 4 to 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Comparsion of Change in serum creatinine from baseline to 1 week, 1 month, and 3 months in the two group |
|
| ExclusionCriteria |
| Details |
Changes in urinary biomarkers from baseline to 3 months
Comparison of adverse events between groups
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparsion of Change in serum creatinine from baseline to 1 week, 1 month, and 3 months in the two group |
baseline at 1 week, 1 month, and 3 months in the two group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in urinary biomarkers from baseline to 3 months
Comparison of adverse events between groups
|
baseline to 3 month |
|
|
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 4 |
|
Date of First Enrollment (India)
|
11/02/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 prospective,open label,Randomized controlled trial comparing two steroid regimen in biopsy proven T cell mediated rejection among renal transplant recipients. sixty participients will be randomized equally to recieve either a slow tapering or maintenance low dose steroid regimen following standard pulse thearpy . The primary outcome will be the change in serum creatinine from baseline to 3 months. secondary outcomes will inculde changes in urinary biomarkers and steroid related adverse events between two groups |