Expired Study
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Cincinnati, Ohio 45267


Purpose:

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).


Study summary:

The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.


Criteria:

Inclusion Criteria: 1. Patient diagnosed with End State Renal Disease requiring renal replacement therapy. 2. Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start; 3. Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit; 4. Hemoglobin >7.5 g/dL with or without clinical symptoms; 5. Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period; 6. Signed and dated informed written consent by the subject or his/her legally authorized representative; Exclusion Criteria: 1. In the judgment of the investigator the patient is not a good candidate for the study; 2. Blood transfusion with in the last 90 days from date of Screening; 3. 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; 4. 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; 5. Concurrent or prior treatment within 90 days of Screening with an investigational medication; 6. Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening; 7. Evidence or history of regular alcohol abuse; 8. Screening laboratory result(s) determined to be clinically significant by the investigator; 9. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency; 10. 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; 11. Uncontrolled Diabetes Mellitus (Patients with HbA1c > 9% at screening)


NCT ID:

NCT02437422


Primary Contact:

Principal Investigator
Bassam G Abu Jadweh, MD
University of Cincinnati/ Division of Nephrology


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45267
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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