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Transplant Antibody-Mediated Rejection: Guiding Effective Treatments

NCT03994783 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-04-13

No results posted yet for this study

Summary

This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.

Conditions

  • Kidney Transplant Rejection
  • Antibody-mediated Rejection

Interventions

DRUG

Rituximab

2 intravenous infusions of rituximab or approved biosimilar given 14 days +/- 2 days apart.

DRUG

Methylprednisolone

Intravenous infusion of methylprednisolone

DRUG

Intravenous Immunoglobulin

High dose (2 g/kg total) or Low dose (100 mg/kg, n=7)

PROCEDURE

Plasma Exchange

Blood is removed from the patient and filtered to remove the plasma. Red and white blood cells and platelets are returned to the patient with replacement fluid.

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Kidney Cancer UK

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Michelle Willicombe, MA MRCP MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-07-17
Completion
2023-01-09

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994783 on ClinicalTrials.gov