RituxiMab INDuction in Renal Transplantation

Recruitment status:
Recruiting
Primary Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Recruitment countries:
United Kingdom
Health condition studied:
Function of Renal Transplant
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: Hydrocortisone
Drug: Mycophenylate mofetil
Drug: Prednisolone
Drug: Rituximab
Drug: Tacrolimus
Key inclusion and exclusion 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
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Estimated GFR (calculated using the Cockcroft-Gault formula)
Secondary outcomes:
Allograft survival
Biopsy proven acute rejection (based on Banff classification)
Changes in B and T cell repertoire
Infection rate
Patient Survival
Target sample size:
612
Study type:
Interventional
Study design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:
  • Name:   Nizam Mamode, MD FRCS(Gen)
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Guy's and St Thomas' NHS Foundation Trust
  • Name:   Nizam Mamode, MD FRCS(Gen)
  • Address: 
  • Phone:  +44 20 7188 1543
  • Email:  nizam.mamode@gstt.nhs.uk
  • Affiliation: 

Technical details

Scientific title:
A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Astellas Pharma Europe Ltd.
Main ID:
NCT01095172
Secondary ID:
RituxiRT
2009-017066-23
9154
95769119
Register:
ClinicalTrials.gov
Date of registration:
26/03/2010
Date of first enrollment:
November 2010
Last refreshed:
10 February 2014

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