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Clinical Trials/ISRCTN95769119
ISRCTN95769119
Completed
Phase 4

A phase IV open label randomised controlled trial of rituximab in induction therapy for living donor renal transplantation

Guy's and St Thomas' Hospital NHS Foundation Trust (UK)0 sites316 target enrollmentDecember 15, 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
ive donor renal transplantation
Sponsor
Guy's and St Thomas' Hospital NHS Foundation Trust (UK)
Enrollment
316
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 15, 2009
End Date
November 16, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Guy's and St Thomas' Hospital NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Adult patients aged over 18 years, either sex
  • 2\. Receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
  • 3\. Have given written informed consent

Exclusion Criteria

  • Amendments as of 22/12/2010:
  • Point 8 of the below exclusion criteria has been amended to read as follows:
  • 8\. Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
  • Initial information at time of registration:
  • 1\. Previous other organ transplants lost through acute rejection
  • 2\. Patients undergoing antibody removal
  • 3\. Patients with other organ transplants
  • 4\. Patients previously treated with cylophosphamide, ATG, OKT3 or rituximab
  • 5\. Patients with white cell count below 4,500/mm^3
  • 6\. Patients with platelet count below 1,500/mm^3

Outcomes

Primary Outcomes

Not specified

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