Renal Insufficiency, Chronic
Conditions
Brief summary
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).
Detailed description
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
Interventions
BIOLOGICALSANGUINATE
Single two-hour infusion of SANGUINATE
Sponsors
Prolong Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion | 90 days | Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays | 90 days | Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA) |
| Mean change in the calculated panel reactive antibody (CPRA) | 90 days | Antibody testing |
| Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays | 90 Days | Antibody testing |
| Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays | 90 days | Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA) |
| Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant) | 22 Days | — |
| Percent of patients with an increase in the overall strength of HLA-Antibodies | 90 Days | Antibody testing |
| Percent of patients with an increase in CPRA | 90 Days | Antibody testing |
Countries
United States
Outcome results
None listed