Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery

NCT05152641 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: BGE-117-203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the safety and tolerability of BGE-117 and gain information on the effectiveness of different doses when given to patients 65 years or older with moderate to severe anemia following major hip surgery. BGE-117 is given once daily in a capsule by mouth for up to 12 weeks. Patients are also given oral iron supplements. Anemia following surgery has been associated with decreases in patient functioning. This study will measure improvement of anemia, as well as various patient functioning.

Conditions

Acute Posthemorrhagic Anemia

Keywords

Anemia; BGE-117; Hip; Surgery; Postoperative; BioAge

Outcome Measures

Primary Outcomes (1)

• Time to 2.0 g/dL Increase in Hemoglobin Level

  The time to a 2.0 g/dL increase in hemoglobin level over the postoperative baseline hemoglobin level. The primary comparison is the high-dose group compared to placebo. Note: Baseline hemoglobin level is the postoperative hemoglobin level most recently obtained before the start of investigational product administration.

  Up to Day 85

Secondary Outcomes (39)

• Hemoglobin Level from Baseline

  Day 8, 15, 22, 29, 36, 43, 57, and 85

• Hemoglobin Level from Nadir Hemoglobin

  Day 8, 15, 22, 29, 36, 43, 57, and 85

• Time to 1.0 g/dL Increase in Hemoglobin Level

  Up to Day 85

• Time to 3.0 g/dL Increase in Hemoglobin Level

  Up to Day 85

• Hemoglobin Level Return to Baseline for Elective Hip Replacement

  Day 8, 15, 22, 29, 36, 43, 57, and 85

Other Outcomes (20)

• Days Alive and At Home (DAH)

  Day 90

• Days Alive and At Home (DAH)

  Day 120

• Days Alive and At Home (DAH)

  Day 183

Study Arms (4)

BGE-117 4mg

EXPERIMENTAL

BGE-117 4mg, Capsules, Oral-administered Once Per Day up to 12 weeks Ferrous sulfate 325mg, Tablets, Oral-administered 3 Times Per Week up to 12 weeks

Drug: BGE-117, 4mg; Dietary Supplement: Ferrous Sulfate

BGE-117 8mg

EXPERIMENTAL

BGE-117 8mg, Capsules, Oral-administered Once Per Day up to 12 weeks Ferrous sulfate 325mg, Tablets, Oral-administered 3 Times Per Week up to 12 weeks

Drug: BGE-117, 4mg; Dietary Supplement: Ferrous Sulfate

BGE-117 16mg

EXPERIMENTAL

BGE-117 16mg, Capsules, Oral-administered Once Per Day up to 12 weeks Ferrous sulfate 325mg, Tablets, Oral-administered 3 Times Per Week up to 12 weeks

Drug: BGE-117, 4mg; Dietary Supplement: Ferrous Sulfate; Drug: BGE-117, 12mg

Placebo

PLACEBO COMPARATOR

Matching Placebo Capsules, Oral-administered Once Per Day up to 12 weeks Ferrous sulfate 325mg, Tablets, Oral-administered 3 Times Per Week up to 12 weeks

Dietary Supplement: Ferrous Sulfate; Other: Matching Placebo

Interventions

BGE-117, 4mg DRUG

BGE-117, 4mg Capsules

BGE-117 16mg; BGE-117 4mg; BGE-117 8mg

Ferrous Sulfate DIETARY_SUPPLEMENT

Ferrous Sulfate, 325mg Tablets

BGE-117 16mg; BGE-117 4mg; BGE-117 8mg; Placebo

Matching Placebo OTHER

Matching Placebo to BGE-117 Capsules

Placebo

BGE-117, 12mg DRUG

BGE-117, 12mg Capsules

BGE-117 16mg

Eligibility Criteria

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

You may qualify if:

• Alert and able to voluntarily provide written, signed, and dated informed consent
• ≥ 65 years of age at the time of completing informed consent
• Major hip surgery, that has occurred within the previous 7 days or is scheduled to occur within the next 7 days, defined as:
• Unilateral or bilateral total or partial hip arthroplasty or revision OR
• Hip fracture repair surgery scheduled or performed within 48 hours after hospital admission (either fracture repair or total or partial hip replacement)
• Postoperative anemia defined as a hemoglobin level ≤ 10.0 g/dL and ≥ 7.0 g/dL from postoperative Day 1 to postoperative Day 7
• For hip fracture subjects only: score between 1 and 5 on the Clinical Frailty Scale (CFS) at baseline before fracture
• Estimated glomerular filtration rate (eGFR) of ≥ 60 mL/min/m2 as measured by the Modification of Diet in Renal Disease (MDRD) method
• Current or planned perioperative use of mechanical or chemical antithrombotic prophylaxis in accordance with local standard of care

You may not qualify if:

• Any current unstable medical condition that the investigator considers would put the subject at unacceptable risk, affect study compliance, or prevent the understanding of the study's objectives or investigational procedures or possible consequences; for example, increased risk of falls that is judged to be clinically significant, clinically significant autonomic dysfunction, active infections requiring antimicrobial treatment
• History of thromboembolic disease in the previous 6 months
• Other medically significant injuries (e.g., head injuries, internal bleeding, or other as judged by the study investigator) that occur concurrently with hip fractures that complicate endpoint assessments, subject safety, and/or study conduct
• History of seizures within the previous 2 years
• History of coagulation disorder (e.g., Factor V Leiden, idiopathic thrombocytopenic purpura) or use of concomitant medications that increase the risk of thromboembolic events (TEEs) as judged by the study investigator
• Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system
• QTcF \> 500 msec or QTcF \> 530 msec in subjects with bundle branch block. A triplicate electrocardiogram (ECG) should be performed if the initial ECG indicates prolonged QTc interval using the automated or manually calculated QTcF value.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 3 × the upper limit of normal (ULN) (Historical standard-of-care laboratory results may be used to confirm eligibility if collected within 14 days before informed consent)
• Bilirubin level \> 1.5 × ULN (isolated bilirubin level \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%) (Historical standard of care laboratory results may be used to confirm eligibility if collected within 14 days before informed consent)
• Recent or planned administration of an erythropoietin stimulating agent (ESA) or a HIF-PHI within 12 weeks of informed consent
• History of malignant hypertension or current uncontrolled hypertension (average systolic blood pressure ≥ 160 mmHg and/or average diastolic blood pressure ≥ 100 mmHg based on 3 readings). Blood pressure should be measured after 5 minutes of unattended rest, with 2 repeated readings 1 to 2 minutes apart
• History of diabetic retinopathy
• History or diagnosis of any of the following:
• Anemia due to pernicious anemia, thalassemia, sickle cell anemia, sickle trait, or myelodysplastic syndromes
• Bone-marrow hypoplasia or pure red cell aplasia

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (1)

Renal Research

Gosford, New South Wales, 2250, Australia

Location

MeSH Terms

Conditions

Anemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-04

Locations

AU (1)