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Rituximab as Induction Therapy in ABO compatible Living Donor Renal Transplantation

A Randomized Controlled Trial Of Rituximab As Induction Therapy In Living Donor Renal Transplantation - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108135
Enrollment
60
Registered
2026-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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: 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 befor

Sponsors

Muljibhai Patel Society for reasearch in Nephro Urology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To assess graft and patient outcome after single dose Rituximab induction after 1 year in ABO compatible and DSA negative kidney transplant patientsTimepoint: To assess Anti DSA titers at baseline and after 1 year

Secondary

MeasureTime frame
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. Timepoint: At 12 months

Countries

India

Contacts

Public ContactDrSishir Gang

Muljibhai Patel Urological Hospital, Nadiad

sishirgang@hotmail.com9824360818

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026