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

Renal Insufficiency, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437422
• Other study ID #: SGTP-001
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2015
• Est. completion date: November 18, 2015

Study information

• Verified date: May 2018
• Source: Prolong Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 18, 2015
• Est. primary completion date: November 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Biological:
• SANGUINATE
Single two-hour infusion of SANGUINATE

Locations

Country	Name	City	State
United States	University of Cincinnati/ Division of Nephrology	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Prolong Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mean change in the calculated panel reactive antibody (CPRA)	Antibody testing	90 days
Secondary	Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays	Antibody testing	90 Days
Secondary	Percent of patients with an increase in CPRA	Antibody testing	90 Days
Secondary	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
Secondary	Percent of patients with an increase in the overall strength of HLA-Antibodies	Antibody testing	90 Days