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

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioAge Labs, Inc.

Criteria

Inclusion Criteria:

1. Alert and able to voluntarily provide written, signed, and dated informed consent

2. ≥ 65 years of age at the time of completing informed consent

3. 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)

4. Postoperative anemia defined as a hemoglobin level ≤ 10.0 g/dL and ≥ 7.0 g/dL from postoperative Day 1 to postoperative Day 7

5. For hip fracture subjects only: score between 1 and 5 on the Clinical Frailty Scale (CFS) at baseline before fracture

6. Estimated glomerular filtration rate (eGFR) of ≥ 60 mL/min/m2 as measured by the Modification of Diet in Renal Disease (MDRD) method

7. Current or planned perioperative use of mechanical or chemical antithrombotic prophylaxis in accordance with local standard of care

Exclusion Criteria:

1. 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

2. History of thromboembolic disease in the previous 6 months

3. 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

4. History of seizures within the previous 2 years

5. 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

6. Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system

7. 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.

8. 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)

9. 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)

10. Recent or planned administration of an erythropoietin stimulating agent (ESA) or a HIF-PHI within 12 weeks of informed consent

11. 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

12. History of diabetic retinopathy

13. History or diagnosis of any of the following:

1. Anemia due to pernicious anemia, thalassemia, sickle cell anemia, sickle trait, or myelodysplastic syndromes

2. Bone-marrow hypoplasia or pure red cell aplasia

3. Androgen deprivation therapy within the previous 12 months or radiation treatment for prostate cancer

4. Myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack, or prothrombotic arrhythmia or condition (e.g., untreated/uncontrolled atrial fibrillation) within 6 months before informed consent or during the Screening Period

5. Active malignancy and/or receiving anti cancer treatment within 12 weeks of informed consent (squamous cell or basal cell carcinoma of the skin are excluded from this criterion). Subjects who have planned initiation of cancer therapies during the study period (such as, but not limited to, chemotherapy, radiotherapy) are excluded.

14. Planned intravenous (IV) iron therapy scheduled to start after informed consent and to continue during the expected time of participation in the study

15. Presence of acute kidney injury (AKI) based upon the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines:

1. Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours, or

2. Increase in serum creatinine to ≥ 1.5 times the value at baseline, which is known or presumed to have occurred within the previous 7 days

16. Chronic bleeding condition such as active gastrointestinal (GI) bleeding

17. Inability or unwillingness to adhere to protocol specified visits, procedures, and contraception requirements

18. Receipt of an investigational drug or device within 30 days before informed consent

19. Previously screened for or enrolled in the BGE-117-203 study

20. Known allergy to or intolerance of BGE-117, or other components of the IP (BGE-117 or matching placebo)

21. Known allergy to ferrous sulfate preparations