EUCTR2009-017066-23-GB
Active, not recruiting
Not Applicable
A randomized trial of Rituximab in induction therapy for living donor renal transplantation - Randomized trial of rituximab in renal transplantation
Guys and St Thomas Foundation Trust0 sitesMarch 17, 2010
ConditionsEnd stage renal diseaserenal function after renal transplantationMedDRA version: 17.0Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End stage renal disease
- Sponsor
- Guys and St Thomas Foundation Trust
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
- •If female and of child bearing potential, taking adequate contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Previous other organ transplants lost through acute rejection
- •Patients undergoing antibody removal.
- •Patients with other organ transplants.
- •Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab.
- •Patients with white cell count below 3\.6x10^9/L; Inclusion of patients with white blood cell counts less than 4\.0x10^9/L, but higher than 3\.6x10^9/L will be left to the discretion of the Principal Investigator.
- •Patients with platelet count below 100x10^9/L
- •Patients who are treated with drugs that are known to have clinically significant interactions with tacrolimus and those treated with 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
Outcomes
Primary Outcomes
Not specified
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