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 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT03470961
Eligibility Criteria:
Inclusion Criteria:
1. with end-stage,diabetic nephropathy(type1or 2)
2. Patients scheduled to undergo SPK with compatible ABO blood type.
3. Peak PRA \<50%
4. Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
5. Patient must have signed the Patient Informed Consent Form.
6. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Exclusion Criteria:
1. Patient is pregnant or breastfeeding.
2. Patient has a positive T-cell crossmatch on the most recent serum specimen.
3. Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
4. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
5. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
6. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
7. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
8. Donor is older than 55 years of age
9. patients with bacterial, viral or mycotic infections which are not under therapeutically control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03470961
Study Brief:
Protocol Section:
NCT03470961