Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis

NCT03612856 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 3G3-18-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB023 (xisomab 3G3) or placebo (at a ratio of 2:1 active: placebo).

Conditions

End Stage Renal Disease; Thrombosis

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (37)

• The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability)

  TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.

  21 days

• Incidence of Bleeding at the HD Vascular Access Site (Safety and Tolerability)

  The number of clinically relevant and non-major bleeding events from the vascular access site. Bleeding from the access site was assessed immediately following decannulation. Pressure was placed on the access site for 10 min. After 10 minutes, the access site was checked for bleeding. If still bleeding, pressure was applied for another 5 minutes and checked again. This was repeated until hemostasis was achieved and the time to hemostasis was recorded. A time greater than 10 min was considered a non-major bleeding event.

  Study Days -7, -5, -3 (pre-dose) 1, 3, and 5 (post-dose)

• The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts (Safety and Tolerability).

  12-lead electrocardiogram measurement. Abnormal electrocardiogram was determined by the study PI. The result was determined to be treatment-related if the abnormal electrocardiogram occurred post-treatment and not pre-treatment. Data from the specified time points (Study Days 6 and 12) were combined by adding the number of participants on each Study Day that showed an abnormal electrocardiogram compared to pre-treatment (Study Day -8 and Study Day 1, pre-dose).

  Study Days -8 and 1, pre-dose (pre-treatment) and Study Days 6 and 12 (post-treatment)

• The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts (Safety and Tolerability).

  Immunogenicity measured by the presence of plasma anti-drug antibodies. Plasma anti-drug antibodies were determined by a validated enzyme-linked immunosorbant assay (ELISA) and the titer of anti-drug antibodies present in patient plasma on Study day 12 was compared to the titer of anti-drug antibodies compared to Study day 1, predose.

  Study day 1 (predose) and Study Day 12

• The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.

  Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature were determined by the study PI. The result was determined to be treatment related if the change in body temperature occurred at any time post-treatment and not pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.

  Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in respiratory rate occurred post-treatment compared to pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.

  Systolic and diastolic blood pressure will be measured in mmHg. Clinically significant changes in blood pressure were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in blood pressure occurred post-treatment compared to pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.

  Heart rate will be measured in beats per minute. Clinically significant changes in heart rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in heart rate occurred post-treatment compared to pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Activated Partial Thromboplastin Time (aPTT), Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.

  Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in aPTT occurred post-treatment compared to pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Prothrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.

  Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in prothrombin time occurred post-treatment compared to pre-treatment.

  Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).

• The Number of Subjects With Clinically Significant Changes in Bilirubin (Total and Direct) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Bilirubin (total and direct) levels in the blood will be measured in mg/dL. Clinically significant changes in bilirubin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in bilirubin occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Alkaline Phosphatase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Alkaline phosphatase levels in the blood will be measured in U/L. Clinically significant changes in alkaline phosphatase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in alkaline phosphatase occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Aspartate Aminotransferase (AST) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  AST levels in the blood will be measured in U/L. Clinically significant changes in aspartate aminotransferase (AST) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in AST occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Alanine Aminotransferase (ALT) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  ALT levels in the blood will be measured in U/L. Clinically significant changes in alanine aminotransferase (ALT) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in ALT occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Lactate Dehydrogenase (LDH) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  LDH levels in the blood will be measured in U/L. Clinically significant changes in lactate dehydrogenase (LDH) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in LDH occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Albumin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Albumin levels in the blood will be measured in g/dL. Clinically significant changes in albumin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in albumin occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Sodium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Sodium levels will be measured in mEq/L. Clinically significant changes in sodium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in sodium levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Potassium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Potassium levels will be measured in mEq/L. Clinically significant changes in potassium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in potassium levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Chloride Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Chloride levels will be measured in mEq/L. Clinically significant changes in chloride levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in chloride levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Blood glucose levels will be measured in mg/dL. Clinically significant changes in glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in glucose occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Creatinine Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.

  Creatinine levels will be measured in mg/dL. Clinically significant changes in creatinine levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in creatinine levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Hemoglobin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Hemoglobin levels will be measured in g/dL. Clinically significant changes in hemoglobin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hemoglobin occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Hematocrit Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Hematocrit levels will be measured in %. Clinically significant changes in hematocrit were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hematocrit occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Total Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Total leukocyte counts will be measured in 10˄3/uL. Clinically significant changes in total leukocyte count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in total leukocyte count occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Differential Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Differential leukocyte counts will be measured in %. Clinically significant changes in differential leukocyte counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in differential leukocyte counts occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Red Blood Cell Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Red blood cell count will be measured in 10˄6/uL. Clinically significant changes in red blood cell counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in red blood cell counts occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Platelet Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.

  Platelet count will be measured in 10˄3/uL. Clinically significant changes in platelet count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in platelet count occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine pH, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  pH of the urine will be measured. Clinically significant changes in urine pH were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine pH occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Specific Gravity, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Specific gravity of the urine will be evaluated. Clinically significant changes in urine specific gravity were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine specific gravity occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Protein Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Protein levels in the urine will be evaluated. Clinically significant changes in urine protein levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine protein levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Glucose levels in the urine will be evaluated. Clinically significant changes in urine glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine glucose levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Ketone Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Ketone levels in the urine will be evaluated. Clinically significant changes in urine ketone levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine ketone levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Bilirubin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Bilirubin levels in the urine will be evaluated. Clinically significant changes in urine bilirubin levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine bilirubin levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Blood Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Blood levels in the urine will be evaluated. Clinically significant changes in urine blood levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine blood levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Nitrite Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Nitrite levels in the urine will be evaluated. Clinically significant changes in urine nitrite levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine nitrite levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Urobilinogen Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Urobilinogen levels in the urine will be evaluated. Clinically significant changes in urine urobilinogen levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine urobilinogen levels occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

• The Number of Subjects With Clinically Significant Changes in Urine Leukocyte Esterase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).

  Leukocyte esterase levels in the urine will be evaluated. Clinically significant changes in urine leukocyte esterase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine leukocyte esterase occurred post-treatment compared to pre-treatment.

  Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Secondary Outcomes (15)

• Hemodialysis Efficiency as Measured by Frequency of Clotting on the Dialysis Filters and Circuit (Pharmacodynamic Outcome).

  At each hemodialysis session (pre-dose days: study day -7, -5, -3, and post-dose dose days: study day 1, 3, and 5)

• Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).

  21 days

• Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.

  21 days

• Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).

  21 days

• Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).

  21 days

Study Arms (3)

AB023 (xisomab 3G3)- Dose 1

EXPERIMENTAL

Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.

Drug: AB023- Dose 1

AB023 (xisomab 3G3)- Dose 2

EXPERIMENTAL

Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.

Drug: AB023-Dose 2

placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo.

Drug: placebo

Interventions

AB023- Dose 1 DRUG

Participants will receive a single dose of 0.25 mg/kg AB023.

Also known as: xisomab 3G3- Dose 1

AB023 (xisomab 3G3)- Dose 1

AB023-Dose 2 DRUG

Participants will receive a single dose of 0.5 mg/kg AB023.

Also known as: xisomab 3G3- Dose 2

AB023 (xisomab 3G3)- Dose 2

placebo DRUG

Participants will receive a single dose of placebo.

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ESRD maintained on stable outpatient HD regimen, using an established (\> 3 months) and normally functioning, regular flow, uninfected first mature AV fistula (or AV graft) and skin consistent with standard chronic HD access injuries, and HD stability defined as Kt/V ≥ 1.2 within 3 months prior to screening at a healthcare center for \> 3 months from screening.
• On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well maintained AV fistula (or AV graft), expected and plan to continue this throughout and for at least 3 months beyond the study.
• Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements and study related procedures.
• Willing to be confined to the CRU for the duration of the study, able to comply with all study-related requirements, and able to adhere to study restrictions and visit schedules.
• Male or female, between 18 and 80 years of age (inclusive) at the time of screening.
• BMI of ≥ 18 at the time of screening.
• Considered by the PI to be clinically stable with respect to underlying ESRD, based on medical evaluation that includes medical and surgical history, and a complete physical examination including vital signs, ECG, and clinical laboratory test results at screening. Repeat assessments are permitted for any laboratory, ECG, or vital sign parameter required for enrollment.
• Female patients must be of non-childbearing potential and must have undergone one of the following:
• sterilization procedures at least 6 months prior to dosing:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status as per PI or designee judgment.
• Male patients must either be sterile (vasectomy with history of a negative sperm count following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female patients) from the time of screening until 90 days after study drug administration. Male patients must agree not to donate sperm for a period of 90 days after study drug administration.

You may not qualify if:

• Patients must not be enrolled in the study if they meet any of the following criteria:
• Documented history of acute vasoocclusive thrombotic event (acute coronary syndrome, stroke or transient ischemic attack, venous thromboembolic event), or vascular access fistula or AV graft failure in the past 3 months.
• With the exception of unfractionated heparin during HD, concomitant or prior use of anticoagulant/antiplatelet agents (e.g., low molecular weight heparins, warfarin, apixaban, bivalirudin, ticagrelor, edoxaban, dabigatran, rivaroxaban, clopidogrel, prasugrel, ticlopidine, eptifibatide, tirofiban, dipyridamole, diclofenac, and all other NSAIDs) that may affect hemostasis for 2 weeks prior to check-in on Day -8 and throughout the study.
• Use of unfractionated heparin for HD sessions from check-in on Day -8 and throughout the study.
• Any clinically significant (CS) concomitant disease or condition (including treatment for such conditions) that, in the opinion of the PI, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
• Any other CS abnormalities in laboratory test results at screening that would, in the opinion of the PI, increase the patient's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
• Pregnant (positive pregnancy test) at screening or check-in on Day -8. If serum human chorionic gonadotropin (hCG) pregnancy test results are indeterminate, follow-up testing should be performed to determine eligibility.
• All female patients will not be pregnant and will have a negative pregnancy test at screening and check-in on Day -8, with the following exception: females receiving dialysis with an indeterminate pregnancy test result or persistently low hCG resulting in a false positive pregnancy test may be included in the study at the discretion of the PI. Postmenopausal patients with a result outside the postmenopausal range or an indeterminate pregnancy test will undergo additional testing with FSH to confirm postmenopausal status prior to study enrollment.
• Treatment with another investigational drug or device study within 30 days (or 5 half lives, whichever is longer) prior to check-in on Day -8.
• Acute illness that is considered by the PI to be CS within 2 weeks of check-in on Day 8.
• Currently have established underlying inherited or acquired symptomatic bleeding disorders and/or are at risk for excessive bleeding per PI judgment or current active bleeding (e.g., gastrointestinal, intracranial), aside from minor bleeding from the puncture site on the AV fistula or AV graft, which would be expected to occur during the dialysis procedure, with the following values:
• Platelet count \< 100,000 cells/mm3 (if \< 100,000 but \> 75,000 cells/mm3, with permission of PI and medical monitor) at screening
• INR \> 1.4 at screening
• aPTT up to 1.2 x ULN (if \>1.2x ULN up to \< 1.5 x ULN, with permission of PI and medical monitor) at screening
• ALT or AST \> 2 x ULN at screening

Sponsors & Collaborators

• Aronora, Inc.: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Publications (2)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

• Lorentz CU, Tucker EI, Verbout NG, Shatzel JJ, Olson SR, Markway BD, Wallisch M, Ralle M, Hinds MT, McCarty OJT, Gailani D, Weitz JI, Gruber A. The contact activation inhibitor AB023 in heparin-free hemodialysis: results of a randomized phase 2 clinical trial. Blood. 2021 Dec 2;138(22):2173-2184. doi: 10.1182/blood.2021011725.

  PMID: 34086880 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Thrombosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Christina U. Lorentz
• Organization: Aronora, Inc.

christina.lorentz@aronorabio.com

503-964-0250

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 2, 2018
• Study Start: October 29, 2018
• Primary Completion: July 6, 2019
• Study Completion: July 6, 2019
• Last Updated: March 7, 2024
• Results First Posted: July 22, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data underlying the reported results will be made available 3 months after publication in a peer-reviewed journal for a period of 5 years.
• Access Criteria: Potential parties from other organizations can learn about study data and identify whether it could be suitable for their research purposes though summary information (ClinicalTrials.gov, Pubmed) that will be readily available on our website. Requests for data can be made directly to Aronora, Inc.

Locations

US (1)