Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437422
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Biological: SANGUINATE Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : November 18, 2015
Actual Study Completion Date : November 18, 2015


Arm Intervention/treatment
Experimental: SANGUINATE
Single infusion of SANGUINATE
Biological: SANGUINATE
Single two-hour infusion of SANGUINATE
Other Name: (pegylated carboxyhemoglobin bovine)




Primary Outcome Measures :
  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 [ Time Frame: 90 days ]
    Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.


Secondary Outcome Measures :
  1. Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays [ Time Frame: 90 days ]
    Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)

  2. Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays [ Time Frame: 90 days ]
    Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)

  3. Mean change in the calculated panel reactive antibody (CPRA) [ Time Frame: 90 days ]
    Antibody testing

  4. Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays [ Time Frame: 90 Days ]
    Antibody testing

  5. Percent of patients with an increase in CPRA [ Time Frame: 90 Days ]
    Antibody testing

  6. 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 ]
  7. Percent of patients with an increase in the overall strength of HLA-Antibodies [ Time Frame: 90 Days ]
    Antibody testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437422


Locations
Layout table for location information
United States, Ohio
University of Cincinnati/ Division of Nephrology
Cincinnati, Ohio, United States, 45267-0585
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Bassam G Abu Jadweh, MD University of Cincinnati/ Division of Nephrology
Layout table for additonal information
Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02437422    
Other Study ID Numbers: SGTP-001
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases