Clinical trial NCT02437422: Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Prolong Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: 90 days
Secondary outcomes:
measure: Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
timeFrame: 90 days
measure: Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
timeFrame: 90 days
measure: Mean change in the calculated panel reactive antibody (CPRA)
timeFrame: 90 days
measure: Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
timeFrame: 90 Days
measure: Percent of patients with an increase in CPRA
timeFrame: 90 Days
measure: Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
timeFrame: 22 Days
measure: Percent of patients with an increase in the overall strength of HLA-Antibodies
timeFrame: 90 Days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati/ Division of Nephrology
state: Ohio
Study officials:
affiliation: University of Cincinnati/ Division of Nephrology
name: Bassam G Abu Jadweh, MD
role: PRINCIPAL_INVESTIGATOR
References: