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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04005469
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH.
2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
1. Under the age of 18 years
2. Difficult venous access
3. BMI \> 40 kg/m2
4. Patients with severe clinical gastroparesis as determined by repeated vomiting
5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
6. Known or history of inflammatory bowel disease or bezoars
7. History of diverticulitis, diverticular stricture, and other intestinal strictures
8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study
9. Be receiving any prostanoid therapy to treat portopulmonary hypertension
10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil
11. Have had a failed kidney transplant within the previous 180 days
12. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results
13. Those with significant cardiovascular disease including treatment with inotropes
14. If female, be pregnant or nursing (confirmed by urine test)
15. Presence of a condition or abnormality that in the opinion of the Investigators that would compromise the safety of the patient or the quality of the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04005469
Study Brief:
Protocol Section:
NCT04005469