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Steroid Free Immunosuppression in Live Donor Liver Transplantation

A prospective randomised study on Steroid free immunosuppression with Basiliximab induction Vs Steroid based standard triple drug immunosuppression in adult live donor liver transplantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009508
Enrollment
40
Registered
2017-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver Health Condition 2: null- Patients suffering from end stage liver disease requiring Liver Transplantation.

Interventions

Intervention1: Basiliximab ( 20 mg IV stat on post transplant Day 1 and 5 )( Two doses in total ) With Tacrolimus and Azathioprine: Basiliximab is an IL-2 receptor antibody used as an induction imm

Sponsors

Amrita Institute of Medical Sciences and Research
Lead Sponsor
Dr Sudhindran
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients more than 18 years who are recipients of primary liver allografts from a living donor are included in the study.

Exclusion criteria

Exclusion criteria: Deceased donor liver transplant recipients, Multiorgan transplants, ABO incompatable transplants, Recent steroid therapy, Recent chemotherapy, Intolerance to study medications, H/O CKD / current renal impairment where there is a pre-transplant decision to use basiliximab

Design outcomes

Primary

MeasureTime frame
1)Biopsy proven acute rejection within 24 weeks following transplantation (Incidence and time to rejection). 2)Patient survival & graft survival. Timepoint: 24 weeks post transplant

Secondary

MeasureTime frame
Post transplant metabolic complications, infectious complications,graft functions, renal functions, duration of hospital stay, post transplant vascular/ biliary complications, Quality of lifeTimepoint: 24 weeks post transplant

Countries

India

Contacts

Public ContactK Manikandan

Amrita Institute of Medical Sciences & Research

sudhi@aims.amrita.edu9388623851

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026