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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT04571203
Eligibility Criteria:
Inclusion Criteria:
RECIPIENT INCLUSION CRITERIA:
1. Patient is ≥ 18 years old, and \<65 years of age.
2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.
3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.
4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.
5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.
6. Females have a negative serum pregnancy test.
7. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
8. No known contraindication to administration of rabbit ATG or low dose irradiation.
DONOR INCLUSION CRITERIA:
1. Brain dead donor aged ≥ 16 and ≤ 55
2. Organ Procurement Organization (OPO) consent for vertebral body procurement
3. Organ Procurement Organization consent for research
4. Projected cold ischemia time \<24 hours.
Exclusion Criteria:
RECIPIENT EXCLUSION CRITERIA:
1. Known allergy to rabbit protein.
2. History of malignancy with the exception of non melanoma skin malignancy.
3. Pregnant woman or nursing mother.
4. Body weight \>90kg or BMI \>35.
5. Evidence of HIV 1/2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen.
6. EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.
7. Active bacterial, viral or fungal infection defined as currently taking medication for the infection.
8. Leukopenia (white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.
10. Concern for alcohol or other substance abuse.
11. Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy
12. Panel reactive antibody (PRA) \>80%.
13. Positive donor specific antibody (DSA).
14. Prior or combined organ transplant.
15. Patients with \>5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.
DONOR EXCLUSION CRITERIA:
1. History of malignancy with the exception of non melanoma skin malignancy.
2. History of autoimmune disease.
3. Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.
4. Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.
5. Evidence of systemic infection.
6. Kidney Donor Profile Index (KDPI) \> 70%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04571203
Study Brief:
Protocol Section:
NCT04571203