| CTRI Number |
CTRI/2026/04/108135 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Immunosupression] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rituximab as Induction Therapy in ABO compatible Living Donor Renal Transplantation |
|
Scientific Title of Study
|
A Randomized Controlled Trial Of Rituximab As Induction Therapy In Living Donor 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 |
DrAnjali Patel |
| Designation |
DrNB Nephrology Resident, MD Medicine |
| Affiliation |
Muljibhai Patel Urological Hospital, Nadiad |
| Address |
Department of Nephrology
Muljibhai Patel Urological Hospital, Nadiad
Dr V V Petlad Road
Yogiraj Society
Nadiad
Dr V V Petlad Road
Yogiraj Society
Nadiad
Gujarat
387003
Anand
GUJARAT
387003
India |
| Phone |
9714368677 |
| Fax |
|
| Email |
drpatelanjali100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSishir Gang |
| Designation |
Director of Nephrology departnment |
| Affiliation |
Muljibhai Patel Urological Hospital, Nadiad |
| Address |
Department of Nephrology Muljibhai Patel Urological Hospital, Nadiad
Dr V V Petlad Road
Yogiraj Society
Nadiad
Anand
GUJARAT
387003
India |
| Phone |
9824360818 |
| Fax |
|
| Email |
sishirgang@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSishir Gang |
| Designation |
Director of Nephrology departnment |
| Affiliation |
Muljibhai Patel Urological Hospital, Nadiad |
| Address |
Department of Nephrology
Muljibhai Patel Urological Hospital, Nadiad
Dr V V Petlad Road
Yogiraj Society
Nadiad
Muljibhai Patel Urological Hospital, Nadiad
Dr V V Petlad Road
Yogiraj Society
Nadiad
Gujarat
387003
Anand
GUJARAT
387003
India |
| Phone |
9824360818 |
| Fax |
|
| Email |
sishirgang@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Society for reasearch in Nephro Urology |
| Address |
Muljibhai Patel Urological Hospital
Dr V V Petlad Rd, Yogiraj Society, Nadiad, Gujarat 387003 |
| 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 Anjali Patel |
Muljibhai Urological Hospital Nadiad |
Department of Nephrology
Transplant ward and ICU
Anand
GUJARAT |
9714368677
drpatelanjali100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society For Research in Nephro - Urology Ethics Committee |
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 |
| Comparator Agent |
No Rituximab |
Control group will not receive Rituximab |
| Intervention |
Rituximab |
This group will recieve Injection Rituximab 375 mg/m2 BSA intravenous single dose as an Induction agent in Living Donor Renal Transplantation administered 7 to 21 days before the transplant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients over 18 years receiving their first ABO compatible living donor renal transplant
2.Negative CDC less than 10 percentage of flow crossmatch
3.Negative baseline DSA with MFI less than 1000 by Luminex SAB assay
Written informed consent.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess graft and patient outcome after single dose Rituximab induction after 1 year in ABO compatible and DSA negative kidney transplant patients |
To assess Anti DSA titers at baseline and after 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Biopsy proven acute rejection (Banff classification)
2.Renal function- Serum creatinine and eGFR at 1, 3, 6, 9, 12 months.
3.Infections: BK viremia, CMV viremia, opportunistic infections
4.Adverse Events of Special Interest: Infusion reactions, neutropenia,lymphopenia, hypogammaglobulinemia
5.Hospitalizations and readmissions within 12 months.
|
At 12 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 4 |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="2"
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 will be a prospective, single-center randomized controlled trial evaluating Rituximab as induction therapy in living donor renal transplantation. It will include 60 adult patients (1:1 allocation) undergoing first ABO-compatible, DSA-negative transplant. The rationale is that de novo donor-specific antibodies (DSA) contribute to rejection and graft loss, and rituximab may prevent this via B-cell depletion. The intervention arm will receive a single dose of rituximab 375 mg/m² IV 7–21 days before transplant, while the control arm will not receive induction therapy. All patients will receive standard triple immunosuppression with tacrolimus, mycophenolate mofetil, and steroids. Primary outcomes will be de novo DSA formation and graft survival at 12 months. Secondary outcomes will include acute rejection, patient survival, graft function, infections, adverse effects, and hospitalizations. DSA will be measured using Luminex single antigen assay. Patients will be followed up at 1, 3, 6, 9, and 12 months with clinical and laboratory monitoring. Ethics approval, informed consent, and necessory formalities will be ensured. The hypothesis is that rituximab reduces de novo DSA and improves graft outcomes |