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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04428008
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or greater
* Signed informed consent
* End-stage renal disease (ESRD) who receive hemodialysis 2 or more times each week and are expected to continue on dialysis indefinitely.
Exclusion Criteria:
* Patients on short-term hemodialysis, such as those with transient renal dysfunction associated with acute illness who are projected to have return in renal function
* Patients for whom renal transplantation is anticipated within the next six months
* Patients with an anticipated survival of less than 3 months
* Patients with symptoms that might be attributable to COVID-19 infection
* Patients who test positive for SARS-CoV2
* Patients with active infectious disease requiring antibiotics
* Patients with hospitalization within the previous 3 months for acute myocardial infarction or congestive heart failure
* Patients with advanced malignancy receiving cytotoxic chemotherapy
* Patients with a Karnofsky Performance Scale score of less than 60
* Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant
* Patients with active autoimmune disease on immunosuppressive medication
* Patients receiving Plaquenil
* Participation in an investigational drug or device trial in previous 30 days
* History of allergy or intolerance to Ta1
* Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04428008
Study Brief:
Protocol Section:
NCT04428008