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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05152641




Registration number
NCT05152641
Ethics application status
Date submitted
29/11/2021
Date registered
10/12/2021
Date last updated
5/05/2022

Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Investigating the Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery
Secondary ID [1] 0 0
BGE-117-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Posthemorrhagic Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGE-117, 4mg
Treatment: Other - Ferrous Sulfate
Other interventions - Matching Placebo
Treatment: Drugs - BGE-117, 12mg

Experimental: BGE-117 4mg - 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

Experimental: BGE-117 8mg - 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

Experimental: BGE-117 16mg - 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

Placebo comparator: Placebo - 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


Treatment: Drugs: BGE-117, 4mg
BGE-117, 4mg Capsules

Treatment: Other: Ferrous Sulfate
Ferrous Sulfate, 325mg Tablets

Other interventions: Matching Placebo
Matching Placebo to BGE-117 Capsules

Treatment: Drugs: BGE-117, 12mg
BGE-117, 12mg Capsules
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to 2.0 g/dL Increase in Hemoglobin Level
Timepoint [1] 0 0
Up to Day 85
Secondary outcome [1] 0 0
Hemoglobin Level from Baseline
Timepoint [1] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [2] 0 0
Hemoglobin Level from Nadir Hemoglobin
Timepoint [2] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [3] 0 0
Time to 1.0 g/dL Increase in Hemoglobin Level
Timepoint [3] 0 0
Up to Day 85
Secondary outcome [4] 0 0
Time to 3.0 g/dL Increase in Hemoglobin Level
Timepoint [4] 0 0
Up to Day 85
Secondary outcome [5] 0 0
Hemoglobin Level Return to Baseline for Elective Hip Replacement
Timepoint [5] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [6] 0 0
1.0 g/dL Improvement in Hemoglobin Level
Timepoint [6] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [7] 0 0
2.0 g/dL Improvement in Hemoglobin Level
Timepoint [7] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [8] 0 0
3.0 g/dL Improvement in Hemoglobin Level
Timepoint [8] 0 0
Day 8, 15, 22, 29, 36, 43, 57, and 85
Secondary outcome [9] 0 0
All-Cause Mortality
Timepoint [9] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [10] 0 0
Hospital Readmission - Any Cause
Timepoint [10] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [11] 0 0
Hospital Readmission - Surgery-Related
Timepoint [11] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [12] 0 0
Surgical Complications
Timepoint [12] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [13] 0 0
Surgical Complications by Clavien-Dindo Classification
Timepoint [13] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [14] 0 0
Change in Ambulation Status
Timepoint [14] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [15] 0 0
Days Alive and At Home (DAH)
Timepoint [15] 0 0
Day 30
Secondary outcome [16] 0 0
Days Alive and At Home (DAH)
Timepoint [16] 0 0
Day 60
Secondary outcome [17] 0 0
Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (AUC(0-24)/Dose)
Timepoint [17] 0 0
Day 1, 43, and 85
Secondary outcome [18] 0 0
Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Clearance)
Timepoint [18] 0 0
Day 1, 43, and 85
Secondary outcome [19] 0 0
Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Volume of Distribution)
Timepoint [19] 0 0
Day 1, 43, and 85
Secondary outcome [20] 0 0
Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Half-Life)
Timepoint [20] 0 0
Day 1, 43, and 85
Secondary outcome [21] 0 0
Subjects Requiring a Dose Decrease
Timepoint [21] 0 0
Up to Day 85
Secondary outcome [22] 0 0
Mean Dose at End of Study
Timepoint [22] 0 0
Day 85
Secondary outcome [23] 0 0
Disposition after Hospital Discharge
Timepoint [23] 0 0
Up to Day 85
Secondary outcome [24] 0 0
Hemoglobin Response as a Function of Iron Status and Hepcidin
Timepoint [24] 0 0
Up to Day 85
Secondary outcome [25] 0 0
Hemoglobin Response as a Function of Clinical Outcome Assessment
Timepoint [25] 0 0
Up to Day 85
Secondary outcome [26] 0 0
Quality of Recovery-15 (QoR-15) Questionnaire
Timepoint [26] 0 0
Day 8, 15, 22, and 29
Secondary outcome [27] 0 0
Visual Analog Scale for Pain (VAS-Pain)
Timepoint [27] 0 0
Up to Day 15
Secondary outcome [28] 0 0
World Health Organization Disability Assessment Schedule (WHODAS) Questionnaire
Timepoint [28] 0 0
Day 29, 57, and 85
Secondary outcome [29] 0 0
European Quality of Life Five Day (EQ-5D-5L) Questionnaire
Timepoint [29] 0 0
Day 15, 43, and 85
Secondary outcome [30] 0 0
6-minute Walk Test (6MWT) Distance
Timepoint [30] 0 0
Day 15, 43, and 85
Secondary outcome [31] 0 0
Timed Up and Go (TUG) Test
Timepoint [31] 0 0
Day 15, 43, and 85
Secondary outcome [32] 0 0
Safety Analyses (Treatment-Emergent Adverse Events) - Incidence
Timepoint [32] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [33] 0 0
Safety Analyses (Treatment-Emergent Adverse Events) - Number of Events
Timepoint [33] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [34] 0 0
Safety Analyses (Treatment-Emergent Adverse Events) - Percentage
Timepoint [34] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [35] 0 0
Safety Analyses (Adverse Events) - Individual Summary
Timepoint [35] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [36] 0 0
Safety Analyses (Quantitative Safety Data) - Clinical Laboratory Tests
Timepoint [36] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [37] 0 0
Safety Analyses (Quantitative Safety Data) - Vital Signs
Timepoint [37] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [38] 0 0
Safety Analyses (Quantitative Safety Data) - Wells Score for DVT
Timepoint [38] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)
Secondary outcome [39] 0 0
Safety Analyses (Quantitative Safety Data) - Electrocardiogram (ECG)
Timepoint [39] 0 0
First Dose to Day 85 and Follow-up (Up to Day 183)

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Renal Research - Gosford
Recruitment postcode(s) [1] 0 0
2250 - Gosford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioAge Labs, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05152641