Clinical trial NCT01095172: RituxiMab INDuction in Renal Transplantation
Official title: A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Function of Renal Transplant
Keywords: Immunosuppression
Rituximab
B cell
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Europe Ltd.
First posted: 2010-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
* Patients who have given written informed consent
* Women of child bearing potential taking adequate contraception.

Exclusion Criteria:

* Previous other organ transplants lost through acute rejection
* 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

Primary outcomes:
measure: Estimated GFR (calculated using the Cockcroft-Gault formula)
timeFrame: 1 year
Secondary outcomes:
measure: Biopsy proven acute rejection (based on Banff classification)
timeFrame: 1, 2, 3, 4, 5 years
measure: Allograft survival
timeFrame: 1, 2, 3, 4, 5 years
measure: Patient Survival
timeFrame: 1, 2, 3, 4, 5 years
measure: Infection rate
timeFrame: 1 year
measure: Changes in B and T cell repertoire
timeFrame: 1 year
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: South West Transplant Centre
state: Devon
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals NHS Foundation Trust
state: Kent
city: Glasgow
country: United Kingdom
facility: Glasgow Renal and Transplant Unit
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Kidney Institute
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Nizam Mamode, MD FRCS(Gen)
role: PRINCIPAL_INVESTIGATOR
References: