Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2010-11-30
2022-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab
Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone
Rituximab
375mg/m\^2, single dose given 2-4 weeks prior to transplantation
Tacrolimus
dose calculated to give levels of 3-7ng/ml
Mycophenylate mofetil
Mycophenylate mofetil 2g/day in divided doses
Hydrocortisone
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
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.
Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
Tacrolimus
dose calculated to give levels of 3-7ng/ml
Mycophenylate mofetil
Mycophenylate mofetil 2g/day in divided doses
Hydrocortisone
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
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.
Interventions
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Rituximab
375mg/m\^2, single dose given 2-4 weeks prior to transplantation
Tacrolimus
dose calculated to give levels of 3-7ng/ml
Mycophenylate mofetil
Mycophenylate mofetil 2g/day in divided doses
Hydrocortisone
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have given written informed consent
* Women of child bearing potential taking adequate contraception.
Exclusion Criteria
* Patients undergoing antibody incompatible transplantation
* Patients with other organ transplants
* Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
* Patients with white cell count below 4.0x10\^9/L.
* Patients with platelet count below 100x10\^9/L
* Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
* Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
* Pregnant or breastfeeding women
* Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
* Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
* Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
* Women of child bearing potential not willing to take adequate contraception
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Nizam Mamode
Consultant Surgeon and Reader in Transplant Surgery
Principal Investigators
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Nizam Mamode, MD FRCS(Gen)
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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South West Transplant Centre
Plymouth, Devon, United Kingdom
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, United Kingdom
Glasgow Renal and Transplant Unit
Glasgow, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Sheffield Kidney Institute
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2009-017066-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
95769119
Identifier Type: REGISTRY
Identifier Source: secondary_id
9154
Identifier Type: REGISTRY
Identifier Source: secondary_id
RituxiRT
Identifier Type: -
Identifier Source: org_study_id
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