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CompletedNCT02437422Updated May 23, 2018

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

A Phase 1 interventional study of SANGUINATE in Renal Insufficiency, Chronic, sponsored by Prolong Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-23.

Sponsored by Prolong Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

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Conditions studied

  • Renal Insufficiency, Chronic
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In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 5 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Prolong Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    SANGUINATE

    Single infusion of SANGUINATE

    Biological: SANGUINATE

Interventions

  • BiologicalSANGUINATE

    Single two-hour infusion of SANGUINATE

    Also known as: (pegylated carboxyhemoglobin bovine)

06

What researchers measure

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.

    Time frame: 90 days

Secondary outcomes

  1. 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)

    Time frame: 90 days

  2. 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)

    Time frame: 90 days

  3. Mean change in the calculated panel reactive antibody (CPRA)

    Antibody testing

    Time frame: 90 days

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

    Antibody testing

    Time frame: 90 Days

  5. Percent of patients with an increase in CPRA

    Antibody testing

    Time frame: 90 Days

  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

    Antibody testing

    Time frame: 90 Days

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02437422
Lead sponsor
Prolong Pharmaceuticals
Responsible party
Sponsor
First posted
May 7, 2015
Start date
Jun 5, 2015
Primary completion
Nov 18, 2015
Completion
Nov 18, 2015
Last update
May 23, 2018

Study contacts

Bassam G Abu Jadweh, MD
principal investigator · University of Cincinnati/ Division of Nephrology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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