Effects of standard induction therapy vs. no induction in renal transplant recipients at low immunological risk of graft rejection

Standard induction therapy vs. no induction in low immunological risk renal transplant recipients: a single center, prospective, randomized, open-label, controlled trials. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061771

Enrollment

100

Registered

2024-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: 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,

mixed in 500 ml normal saline or 5% dextrose) Control Intervention1: No induction therapy: No induction immunosuppressant agent will be given to the transplant recipient, only maintenance immunosuppre

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Patients refusing consent for participation in the study Contraindication to Basiliximab or rATG administration High immunological risk

Design outcomes

Primary

Measure	Time frame
Incidence of biopsy proven acute rejection within 3 months following transplantTimepoint: 3 months following transplant	—

Secondary

Measure	Time frame
Delayed graft functionTimepoint: Need of at least one dialysis treatment within the first week post transplant;Incidence of infectious complicationsTimepoint: Within 3 months;Incidence of new onset post transplant diabetes mellitus (PTDM)Timepoint: Within 3 months;Length of first hospital stayTimepoint: From the date of surgery to the date of discharge;Patient and graft survival at 3 months post transplantTimepoint: 3 months;Serum creatinine during post operative hospital stay, at 1 month, 2 months and 3 months post transplant.Timepoint: Till 3 months	—

Measure

Time frame

Delayed graft functionTimepoint: Need of at least one dialysis treatment within the first week post transplant;Incidence of infectious complicationsTimepoint: Within 3 months;Incidence of new onset post transplant diabetes mellitus (PTDM)Timepoint: Within 3 months;Length of first hospital stayTimepoint: From the date of surgery to the date of discharge;Patient and graft survival at 3 months post transplantTimepoint: 3 months;Serum creatinine during post operative hospital stay, at 1 month, 2 months and 3 months post transplant.Timepoint: Till 3 months

—

Countries

India

Contacts

Public ContactDr Ashish Limbani

Post Graduate Institute of Medical Education and Research, Chandigarh.

drshivpgi@gmail.com9914204441

Outcome results

None listed

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