Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease

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)

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 Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Biological: SANGUINATE

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati/ Division of Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SANGUINATE; Single infusion of SANGUINATE	Biological: SANGUINATE; Single two-hour infusion of SANGUINATE; Other Names: (pegylated carboxyhemoglobin bovine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 days
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)	90 days
Mean change in the calculated panel reactive antibody (CPRA)	Antibody testing	90 days
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays	Antibody testing	90 Days
Percent of patients with an increase in CPRA	Antibody testing	90 Days
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	Antibody testing	90 Days

Collaborators and Investigators

• Sponsor: Prolong Pharmaceuticals
• Investigators: Principal Investigator: Bassam G Abu Jadweh, MD, University of Cincinnati/ Division of Nephrology

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2015
• Primary Completion (Actual): November 18, 2015
• Study Completion (Actual): November 18, 2015

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: SGTP-001