Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
Completed · Phase 1
Conditions studied: Renal Insufficiency, Chronic
In brief
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
Key facts
- Study ID
- NCT02437422
- Run by
- Prolong Pharmaceuticals
- People needed
- 5
- Starts
- 2015-06-05
- Expected to finish
- 2015-11-18
- Last updated by the study team
- 2018-05-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
- Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
- Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
- Hemoglobin >7.5 g/dL with or without clinical symptoms;
- Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
- Signed and dated informed written consent by the subject or his/her legally authorized representative;
You may not qualify if…
- In the judgment of the investigator the patient is not a good candidate for the study;
- Blood transfusion with in the last 90 days from date of Screening;
- Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
- Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
- Concurrent or prior treatment within 90 days of Screening with an investigational medication;
- Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening;
- Evidence or history of regular alcohol abuse;
- Screening laboratory result(s) determined to be clinically significant by the investigator;
- Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency;
- Screening laboratory result or laboratory results performed within one year indicating positivity for hepatitis B surface antigens, hepatitis B core antibodies, or hepatitis C antibodies;
- Uncontrolled Diabetes Mellitus (Patients with HbA1c > 9% at screening)
Where it is running
- University of Cincinnati/ Division of Nephrology — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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