RituxiMab INDuction in Renal Transplantation

Function of Renal Transplant Clinical Trial

— ReMIND  

Official title:

A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01095172
• Other study ID #: RituxiRT
• Secondary ID: 2009-017066-2395
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: October 2022

Study information

• Verified date: July 2020
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Function of Renal Transplant

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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	South West Transplant Centre	Plymouth	Devon
United Kingdom	Sheffield Kidney Institute	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated GFR (calculated using the Cockcroft-Gault formula)		1 year
Secondary	Biopsy proven acute rejection (based on Banff classification)		1, 2, 3, 4, 5 years
Secondary	Allograft survival		1, 2, 3, 4, 5 years
Secondary	Patient Survival		1, 2, 3, 4, 5 years
Secondary	Infection rate	New episodes, including (but not restricted to) viral (e.g. CMV, EBV), bacterial (e.g. Urinary Tract Infections with details of causative organism) and fungal infections will be recorded at each assessment time-point.	1 year
Secondary	Changes in B and T cell repertoire		1 year