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 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT04195906
Eligibility Criteria:
Inclusion Criteria:
* Female or male subjects, 18 years of age or older
* Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
* Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface
* CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
* Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.
* Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol
Exclusion Criteria:
* History of treatment with bisphosphonates within 3 months of baseline
* Severely ill subjects without a reasonable expectation of survival for at least 6 months
* Subjects with a scheduled parathyroidectomy during the study period
* Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
* Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria
* Significant noncompliance with dialysis
* History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma
* Clinically significant illness other than CUA within 30 days
* Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
* History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months
* Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.
* Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04195906
Study Brief:
Protocol Section:
NCT04195906