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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01384006
Eligibility Criteria:
Inclusion Criteria:
* Recipients of standard allocation organs or
* Recipients of organs from donors between 50 to 60 years OR a BMI 30-34
* CIT (cold ischemic time) ≤ 12h (only local allocation of organs, optimally the procuring surgical team should be the transplanting team).
and
* negative cross-match
* age \> 18 years
* primary SPK, PAK or PTA
* Patients on standardized immunosuppressive treatment with Tacrolimus (Prograf®), MPA (Myfortic®) \[aiming at center specific trough-level practice\] from day 5 after transplantation (prior to day 5 MMF (Cell Cept®) can be applied as i.v. medication due to reduced gastrointestinal passage and insecure absorption of orally applied medication) and center-specific steroid treatment.
Exclusion Criteria:
* Malignant diseases within 5 years prior to PTA/SPK except for squamous cell carcinoma and basalioma of the skin.
* Pancreas retransplantation.
* Immunized patients with a preformed antibody titer\>5%.
* Women with child bearing potential.
* Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
* Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01384006
Study Brief:
Protocol Section:
NCT01384006