Status:
COMPLETED
Impact of Rituximab (RTx) Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Heidelberg University
German Cancer Research Center
Conditions:
Kidney Transplantation
Rituximab (RTx)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients comp...
Detailed Description
Objective. Blood group incompatible (ABOi) LD renal transplantation represents a recognized treatment modality in Germany. In this setting, ethical considerations allow for a detailed study of short- ...
Eligibility Criteria
Inclusion
- De-novo kidney transplantation
- Deceased donors (blood group compatible) and living donors (blood group incompatible / blood group compatible)
- First, second and third renal transplants
- Immunized and non-immunized graft recipients
- Age of recipients 18 years or older
- Negative pregnancy test before transplantation
Exclusion
- Contra-indications to use Tacr and MPS, respectively
- Contra-indications to use Rtx in the group of ABOi LD transplants
- Chronic hepatitis B, C or HIV infection
- Recurrent infectious disease
- Previous hepatitis B, if no prophylactic antiviral therapy is used
- Previous tuberculosis
- Hemoglobin\<8,5g/dl, thrombocytes\<80.000/ul or leucocytes\<3000/ul
- Previous vaccination with a living vaccine \<4 weeks pretransplant
- Significant enterogastric disease such as diverticulitis (contra-indicates MPS treatment)
- Children and adolescents (age less than 18 years)
- Pregnancy and breast-feeding women
- Refusal of an effective contraception in women capable of bearing children
- Combined transplantations such as simultaneous islet/kidney transplants
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01136395
Start Date
January 1 2010
End Date
June 18 2019
Last Update
October 8 2019
Active Locations (1)
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1
Department of Internal Medicine, University of Giessen
Giessen, Germany, D-35392