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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06655857
Eligibility Criteria:
Inclusion Criteria:
* Patient inclusion:
* Provision of signed and dated informed consent from the patient.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Age 18 - 75 years
* eGFR≤20 mL/min/1.73m2 or on maintenance in-center HD.
* Receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center.
* Community dwelling (i.e., not in a nursing home, currently incarcerated).
* Speak English and/or Spanish.
* Provider Inclusion:
* Provision of signed and dated informed consent from the nephrologist.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
* Patient Exclusion:
* Absolute contraindications to KTx:
* Self-reported or documented diagnosis of dementia, or inability to understand the study and complete informed consent. When the participant's understanding is unclear, the CRC will use a modified MOCA screener to determine eligibility.
* Active malignancy (excluding local non-melanoma skin cancer, renal cell carcinoma \<5 cm, early thyroid cancer, and prostate cancer GS≤6).
* Pregnancy (can be re-evaluated post-delivery).
* Active infection. Patients excluded due to active infection will be evaluated at 30 days or after completing full treatment (whichever is later) to determine eligibility. Examples of active infection include:
* Positive cultures or radiographic evidence of infection
* Infected intravascular devices, such as tunneled catheters and pacemakers
* Active histoplasmosis, cryptococcosis, tuberculosis (TB), and nontuberculous mycobacteria
* Previously evaluated by KTx and not listed for specific medical reasons.
* Patients previously evaluated and not listed will be carefully reviewed by site PI for eligibility
* Already listed for KTx.
* Patients on other types of dialysis other than in-center hemodialysis.
* Self-identify as already engaged with a CHW at participating sites to address unmet social needs.
* Planning to move out of the greater NY area in the next 1 year.
* Provider Exclusion:
* Planning to leave their respective institutions in the next 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06655857
Study Brief:
Protocol Section:
NCT06655857