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

NCT02437422 | Completed Phase 1

• 1 other identifier: SGTP-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays

  90 days

• Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays

  90 days

• Mean change in the calculated panel reactive antibody (CPRA)

  90 days

• Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays

  90 Days

• Percent of patients with an increase in CPRA

  90 Days

Study Arms (1)

SANGUINATE

EXPERIMENTAL

Single infusion of SANGUINATE

Biological: SANGUINATE

Interventions

SANGUINATE BIOLOGICAL

Single two-hour infusion of SANGUINATE

Also known as: (pegylated carboxyhemoglobin bovine)

SANGUINATE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (1)

University of Cincinnati/ Division of Nephrology

Cincinnati, Ohio, 45267-0585, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

PEGylated carboxyhemoglobin bovine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bassam G Abu Jadweh, MD

  University of Cincinnati/ Division of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 7, 2015
• Study Start: June 5, 2015
• Primary Completion: November 18, 2015
• Study Completion: November 18, 2015
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

US (1)