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RituxiMab INDuction in Renal Transplantation

NCT01095172 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-22

No results posted yet for this study

Summary

Hypothesis:

* That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.

Aim:

* To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.

Objectives:

* To assess whether B cell depletion affects graft function, acute rejection and complication rates
* To assess whether the T cell response to allotransplantation is impaired by B cell depletion.

Conditions

  • Function of Renal Transplant

Interventions

DRUG

Rituximab

375mg/m\^2, single dose given 2-4 weeks prior to transplantation

DRUG

Tacrolimus

dose calculated to give levels of 3-7ng/ml

DRUG

Mycophenylate mofetil

Mycophenylate mofetil 2g/day in divided doses

DRUG

Hydrocortisone

100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.

DRUG

Prednisolone

Prednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none.

DRUG

Prednisolone

Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    collaborator INDUSTRY

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nizam Mamode, MD FRCS(Gen) · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2020-10-31
Completion
2022-10-31

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 NCT01095172 on ClinicalTrials.gov