Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT01136395
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01136395
Study Brief:
Protocol Section:
NCT01136395