| CTRI Number |
CTRI/2024/01/061771 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of standard induction therapy vs. no induction in renal transplant recipients at low immunological risk of graft rejection |
|
Scientific Title of Study
|
Standard induction therapy vs. no induction in low immunological risk renal transplant recipients: a single center, prospective, randomized, open-label, controlled trials. |
| 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 Ashish Limbani |
| Designation |
Junior Resident, Department of General Surgery. |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of General Surgery,
Level 5, B Block,
Nehru Hospital,
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9978805444 |
| Fax |
|
| Email |
ashishlimbani24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar S P |
| Designation |
Associate Professor, Department of Renal Transplant Surgery. |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of Renal Transplant Surgery,
Level 2, C Block,
Nehru Hospital,
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914204441 |
| Fax |
|
| Email |
drshivpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Limbani |
| Designation |
Junior Resident, Department of General Surgery. |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Department of General Surgery,
Level 5, B Block,
Nehru Hospital,
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9978805444 |
| Fax |
|
| Email |
ashishlimbani24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
| Address |
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India. |
| 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 Ashish Limbani |
Post Graduate Institute of Medical Education and Research, Chandigarh. |
Department of Renal Transplant Surgery,
Level 2, C Block,
Nehru Hospital,
PGIMER, Chandigarh.
Chandigarh
CHANDIGARH |
9978805444
ashishlimbani24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Post Graduate Institute of Medical Education and Research, Chandigarh. |
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 induction therapy |
No induction immunosuppressant agent will be given to the transplant recipient, only maintenance immunosuppressant agent will be given. |
| Intervention |
Standard induction therapy (Injection Basiliximab or Injection rabbit Antithymocyte Globulin) |
Injection Basiliximab (2 doses, 20 mg intravenously as a bolus over 10 seconds, at day 0, within 2 hours before the transplant surgery, and at day 4 post engraftment) or Injection rabbit Antithymocyte Globulin (3 mg/kg, in 3 divided doses, at day 0-prior to reperfusion, day 1 and day 2 post engraftment; mixed in 500 ml normal saline or 5% dextrose) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent for participation in the study
Low immunological risk:
Primary (first) renal transplant
Living kidney donor
3 or less Human Leukocyte Antigen mismatch (HLA A, B, DR matching scheme)
Donor Specific Antibodies (DSAs) less than 1000 Mean Fluorescent Intensity (MFI)
Negative CDC and Flow cytometry crossmatch
|
|
| ExclusionCriteria |
| Details |
Patients refusing consent for participation in the study
Contraindication to Basiliximab or rATG administration
High immunological risk
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of biopsy proven acute rejection within 3 months following transplant |
3 months following transplant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delayed graft function |
Need of at least one dialysis treatment within the first week post transplant |
| Length of first hospital stay |
From the date of surgery to the date of discharge |
| Serum creatinine during post operative hospital stay, at 1 month, 2 months and 3 months post transplant. |
Till 3 months |
| Incidence of infectious complications |
Within 3 months |
| Incidence of new onset post transplant diabetes mellitus (PTDM) |
Within 3 months |
| Patient and graft survival at 3 months post transplant |
3 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 3 |
|
Date of First Enrollment (India)
|
27/01/2024 |
| 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="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
|
End Stage Renal Disease is common in
our country, with the need for renal replacement therapy (RRT) either in the form of dialysis or kidney
transplantation. In patients undergoing renal transplantation,
immunosuppressive therapy is given as induction therapy and maintenance
therapy. According to the KDIGO guidelines, patients at low immunological risk
for acute rejection receive standard induction therapy. However, recent
scientific research has shown that induction therapy in low immunological risk
renal transplant recipients does not confer significant advantage in acute
rejection rates and long term patient or graft survival. It potentially
increases the risk for infections and overall cost of the treatment. We are
conducting this study to find out if renal transplantation without induction
immunosuppressive therapy will affect the short term and long term outcomes in
patients at low immunological risk for acute rejection. We aim to conduct a prospective, randomized
controlled trial to compare the outcomes of no induction therapy vs. standard induction
immunosuppresion, in low immunological risk renal transplant recipients, on
standard tacrolimus, mycophenolate mofetil and corticosteroid based triple
maintenance immunosuppresion.
|