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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]

BGE-117-203

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Posthemorrhagic Anemia

Condition category

Condition code

Blood

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]

Treatment: Drugs

Intervention code [2]

Treatment: Other

Intervention code [3]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Time to 2.0 g/dL Increase in Hemoglobin Level

Timepoint [1]

Up to Day 85

Secondary outcome [1]

Hemoglobin Level from Baseline

Timepoint [1]

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

Secondary outcome [2]

Hemoglobin Level from Nadir Hemoglobin

Timepoint [2]

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

Secondary outcome [3]

Time to 1.0 g/dL Increase in Hemoglobin Level

Timepoint [3]

Up to Day 85

Secondary outcome [4]

Time to 3.0 g/dL Increase in Hemoglobin Level

Timepoint [4]

Up to Day 85

Secondary outcome [5]

Hemoglobin Level Return to Baseline for Elective Hip Replacement

Timepoint [5]

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

Secondary outcome [6]

1.0 g/dL Improvement in Hemoglobin Level

Timepoint [6]

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

Secondary outcome [7]

2.0 g/dL Improvement in Hemoglobin Level

Timepoint [7]

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

Secondary outcome [8]

3.0 g/dL Improvement in Hemoglobin Level

Timepoint [8]

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

Secondary outcome [9]

All-Cause Mortality

Timepoint [9]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [10]

Hospital Readmission - Any Cause

Timepoint [10]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [11]

Hospital Readmission - Surgery-Related

Timepoint [11]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [12]

Surgical Complications

Timepoint [12]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [13]

Surgical Complications by Clavien-Dindo Classification

Timepoint [13]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [14]

Change in Ambulation Status

Timepoint [14]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [15]

Days Alive and At Home (DAH)

Timepoint [15]

Day 30

Secondary outcome [16]

Days Alive and At Home (DAH)

Timepoint [16]

Day 60

Secondary outcome [17]

Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (AUC(0-24)/Dose)

Timepoint [17]

Day 1, 43, and 85

Secondary outcome [18]

Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Clearance)

Timepoint [18]

Day 1, 43, and 85

Secondary outcome [19]

Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Volume of Distribution)

Timepoint [19]

Day 1, 43, and 85

Secondary outcome [20]

Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Half-Life)

Timepoint [20]

Day 1, 43, and 85

Secondary outcome [21]

Subjects Requiring a Dose Decrease

Timepoint [21]

Up to Day 85

Secondary outcome [22]

Mean Dose at End of Study

Timepoint [22]

Day 85

Secondary outcome [23]

Disposition after Hospital Discharge

Timepoint [23]

Up to Day 85

Secondary outcome [24]

Hemoglobin Response as a Function of Iron Status and Hepcidin

Timepoint [24]

Up to Day 85

Secondary outcome [25]

Hemoglobin Response as a Function of Clinical Outcome Assessment

Timepoint [25]

Up to Day 85

Secondary outcome [26]

Quality of Recovery-15 (QoR-15) Questionnaire

Timepoint [26]

Day 8, 15, 22, and 29

Secondary outcome [27]

Visual Analog Scale for Pain (VAS-Pain)

Timepoint [27]

Up to Day 15

Secondary outcome [28]

World Health Organization Disability Assessment Schedule (WHODAS) Questionnaire

Timepoint [28]

Day 29, 57, and 85

Secondary outcome [29]

European Quality of Life Five Day (EQ-5D-5L) Questionnaire

Timepoint [29]

Day 15, 43, and 85

Secondary outcome [30]

6-minute Walk Test (6MWT) Distance

Timepoint [30]

Day 15, 43, and 85

Secondary outcome [31]

Timed Up and Go (TUG) Test

Timepoint [31]

Day 15, 43, and 85

Secondary outcome [32]

Safety Analyses (Treatment-Emergent Adverse Events) - Incidence

Timepoint [32]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [33]

Safety Analyses (Treatment-Emergent Adverse Events) - Number of Events

Timepoint [33]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [34]

Safety Analyses (Treatment-Emergent Adverse Events) - Percentage

Timepoint [34]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [35]

Safety Analyses (Adverse Events) - Individual Summary

Timepoint [35]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [36]

Safety Analyses (Quantitative Safety Data) - Clinical Laboratory Tests

Timepoint [36]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [37]

Safety Analyses (Quantitative Safety Data) - Vital Signs

Timepoint [37]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [38]

Safety Analyses (Quantitative Safety Data) - Wells Score for DVT

Timepoint [38]

First Dose to Day 85 and Follow-up (Up to Day 183)

Secondary outcome [39]

Safety Analyses (Quantitative Safety Data) - Electrocardiogram (ECG)

Timepoint [39]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Renal Research - Gosford

Recruitment postcode(s) [1]

2250 - Gosford

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

BioAge Labs, Inc.

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT05152641

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05152641

Trial Review

Registering a new trial?

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