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Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

NCT01350882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-26

No results posted yet for this study

Summary

Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

Conditions

  • Humoral Rejection in Kidney Transplantation

Interventions

DRUG

MabThera

MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2

DRUG

Physiological serum : sodium chloride, sodium citrate

Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Yvon LEBRANCHU · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • France

Study Locations

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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 NCT01350882 on ClinicalTrials.gov