Back to resultsStudy to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SANGUINATE
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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)
Sites / Locations
- University of Cincinnati/ Division of Nephrology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SANGUINATE
Arm Description
Single infusion of SANGUINATE
Outcomes
Primary Outcome Measures
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
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
Secondary Outcome Measures
Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
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)
Antibody testing
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
Antibody testing
Percent of patients with an increase in CPRA
Antibody testing
Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
Percent of patients with an increase in the overall strength of HLA-Antibodies
Antibody testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02437422
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 5, 2015 (Actual)
Primary Completion Date
November 18, 2015 (Actual)
Study Completion Date
November 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prolong Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SANGUINATE
Arm Type
Experimental
Arm Description
Single infusion of SANGUINATE
Intervention Type
Biological
Intervention Name(s)
SANGUINATE
Other Intervention Name(s)
(pegylated carboxyhemoglobin bovine)
Intervention Description
Single two-hour infusion of SANGUINATE
Primary Outcome Measure Information:
Title
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
Description
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
Description
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Time Frame
90 days
Title
Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
Description
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Time Frame
90 days
Title
Mean change in the calculated panel reactive antibody (CPRA)
Description
Antibody testing
Time Frame
90 days
Title
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
Description
Antibody testing
Time Frame
90 Days
Title
Percent of patients with an increase in CPRA
Description
Antibody testing
Time Frame
90 Days
Title
Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
Time Frame
22 Days
Title
Percent of patients with an increase in the overall strength of HLA-Antibodies
Description
Antibody testing
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassam G Abu Jadweh, MD
Organizational Affiliation
University of Cincinnati/ Division of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati/ Division of Nephrology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
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