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Comparative Efficacy and Safety of Very low dose Thymoglobulin versus Basiliximab Induction Therapy in Low Risk Kidney Transplant Recipients: A Prospective Randomized Controlled Trial

Comparative Efficacy and Safety of Very low dose Thymoglobulin versus Basiliximab Induction Therapy in Low Risk Kidney Transplant Recipients: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260601018
Enrollment
348
Registered
2026-06-01
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Low risk kidney transplant recipients kidney transplantation, very low dose thymoglobulin, low immunological risk, induction therapy, rejection

Interventions

thymoglobulin 25 mg for 3 days,basiliximab 20 mg at day 0 and day 4
Active Comparator Drug,Active Comparator Drug
very low dose ATG,basiliximab

Sponsors

Department of Nephrology, Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. First kidney transplant recipients from a living or deceased donor 2. Age > 20 years 3. Peak and current PRA < 20%, or Single Antigen Bead (SAB) assay < 2,000 MFI 4. Absence of Donor-Specific Antibodies (DSA) in both peak and current sera 5. Cold Ischemia Time (CIT) < 24 hours

Exclusion criteria

Exclusion criteria: 1. Multiple-organ transplantation 2. Recipients with HIV infection 3. High-risk CMV serostatus (Donor CMV IgG positive / Recipient CMV IgG negative) 4. Preformed donor specific HLA antibody 5. ABO-incompatible kidney transplantation 6. HLA identical kidney transplantation 7. Hypersensitivity to thymoglobuliin 8. Baseline leukopenia (wbc count < 2,500 cells/ul ) 9. Recipients who denied participation

Design outcomes

Primary

MeasureTime frame
Rejection 1 year after kidney transplantation Occurrence of biopsy-proven rejection

Secondary

MeasureTime frame
Mortality 1 year after kidney transplantation Incidence of mortality,Graft loss 1 year after kidney transplantation Incidence of graft loss,dnDSA (De novo DSA) 1 year after kidney transplantation Incidence of dnDSA,CMV infection 1 year after kidney transplantation Incidence of CMV infection that required anti-viral therapy,Renal function 1 year after kidney transplantation eGFR,Serious infection 1 year after kidney transplantation Incidence of serious infection that required hospitalization

Countries

Thailand

Contacts

Public ContactAttapong Wongwiwatana

Nephrology Department, Siriraj Hospital, Mahidol University

siavw@hotmail.com024197777

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026