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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

Assessment method [1]

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.

Timepoint [1]

Up to Day 85

Secondary outcome [1]

Hemoglobin Level from Baseline

Assessment method [1]

Change in hemoglobin level from baseline.

Timepoint [1]

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

Secondary outcome [2]

Hemoglobin Level from Nadir Hemoglobin

Assessment method [2]

Change in 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

Assessment method [3]

The time to a 1.0 g/dL increase in hemoglobin level over the postoperative baseline hemoglobin level. Note: Baseline hemoglobin level is the postoperative hemoglobin level most recently obtained before the start of investigational product administration.

Timepoint [3]

Up to Day 85

Secondary outcome [4]

Time to 3.0 g/dL Increase in Hemoglobin Level

Assessment method [4]

The time to a 3.0 g/dL increase in hemoglobin level over the postoperative baseline hemoglobin level. Note: Baseline hemoglobin level is the postoperative hemoglobin level most recently obtained before the start of investigational product administration.

Timepoint [4]

Up to Day 85

Secondary outcome [5]

Hemoglobin Level Return to Baseline for Elective Hip Replacement

Assessment method [5]

Proportion of elective hip replacement subjects who return to preoperative baseline hemoglobin level.

Timepoint [5]

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

Secondary outcome [6]

1.0 g/dL Improvement in Hemoglobin Level

Assessment method [6]

Proportion of subjects with a 1.0 g/dL improvement in hemoglobin level from the postoperative baseline hemoglobin value

Timepoint [6]

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

Secondary outcome [7]

2.0 g/dL Improvement in Hemoglobin Level

Assessment method [7]

Proportion of subjects with a 2.0 g/dL improvement in hemoglobin level from the postoperative baseline hemoglobin value

Timepoint [7]

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

Secondary outcome [8]

3.0 g/dL Improvement in Hemoglobin Level

Assessment method [8]

Proportion of subjects with a 3.0 g/dL improvement in hemoglobin level from the postoperative baseline hemoglobin value

Timepoint [8]

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

Secondary outcome [9]

All-Cause Mortality

Assessment method [9]

The rate of all-cause mortality.

Timepoint [9]

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

Secondary outcome [10]

Hospital Readmission - Any Cause

Assessment method [10]

The rate of hospital readmissions for any cause.

Timepoint [10]

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

Secondary outcome [11]

Hospital Readmission - Surgery-Related

Assessment method [11]

The rate of hospital readmissions for causes related to surgery.

Timepoint [11]

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

Secondary outcome [12]

Surgical Complications

Assessment method [12]

The rate of surgical complications (e.g., dislocation, nonunion, infection, chronic pain, posttraumatic arthritic changes, avascular necrosis).

Timepoint [12]

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

Secondary outcome [13]

Surgical Complications by Clavien-Dindo Classification

Assessment method [13]

The rate of surgical complications as defined by the Clavien-Dindo Classification of = Grade II Defined as follows: Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III-IIIB: Requiring surgical, endoscopic or radiological intervention. Intervention not under general anesthesia. Intervention under general anesthesia. Grade IV-IVb: Life-threatening complication (including CNS complications) requiring IC/ICU-management. Single organ dysfunction (including dialysis). Multiorgan dysfunction. Grade V: Death of a patient.

Timepoint [13]

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

Secondary outcome [14]

Change in Ambulation Status

Assessment method [14]

The time to change in ambulation status (e.g., from ambulation with human assistance to ambulation with assistive device, or to independent ambulation).

Timepoint [14]

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

Secondary outcome [15]

Days Alive and At Home (DAH)

Assessment method [15]

Number of days that the subject has been at home. Home is defined as the subject's place of residence before surgery.

Timepoint [15]

Day 30

Secondary outcome [16]

Days Alive and At Home (DAH)

Assessment method [16]

Number of days that the subject has been at home. Home is defined as the subject's place of residence before surgery.

Timepoint [16]

Day 60

Secondary outcome [17]

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

Assessment method [17]

Single blood samples for pharmacokinetic analysis will be collected just prior to first dose and on Days 43 and 85. Time of last dose and time of blood draw will be collected and these data will be used to attempt to develop a population pharmacokinetic model of BGE-117. If possible, AUC(0-24)/dose will be determined. Age, gender and renal function will be explored as covariates.

Timepoint [17]

Day 1, 43, and 85

Secondary outcome [18]

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

Assessment method [18]

Single blood samples for pharmacokinetic analysis will be collected just prior to first dose and on Days 43 and 85. Time of last dose and time of blood draw will be collected and these data will be used to attempt to develop a population pharmacokinetic model of BGE-117. If possible, clearance will be determined. Age, gender and renal function will be explored as covariates.

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)

Assessment method [19]

Single blood samples for pharmacokinetic analysis will be collected just prior to first dose and on Days 43 and 85. Time of last dose and time of blood draw will be collected and these data will be used to attempt to develop a population pharmacokinetic model of BGE-117. If possible, volume of distribution will be determined. Age, gender and renal function will be explored as covariates.

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)

Assessment method [20]

Single blood samples for pharmacokinetic analysis will be collected just prior to first dose and on Days 43 and 85. Time of last dose and time of blood draw will be collected and these data will be used to attempt to develop a population pharmacokinetic model of BGE-117. If possible, half-life will be determined. Age, gender and renal function will be explored as covariates.

Timepoint [20]

Day 1, 43, and 85

Secondary outcome [21]

Subjects Requiring a Dose Decrease

Assessment method [21]

The proportion of subjects requiring a decrease in the investigational product dose. Dose decreases are allowed for safety, tolerability, and to maintain an approximate rate of hemoglobin increase of = 1.5 g/dL every 2 weeks, and a maximum hemoglobin level of 12.0 g/dL.

Timepoint [21]

Up to Day 85

Secondary outcome [22]

Mean Dose at End of Study

Assessment method [22]

The mean dose at the end of the treatment period including any dose decreases and/or termination of dose.

Timepoint [22]

Day 85

Secondary outcome [23]

Disposition after Hospital Discharge

Assessment method [23]

The location where the subject is discharged following discharge from the hospital (e.g., home, rehabilitation center, nursing-care facility, etc.)

Timepoint [23]

Up to Day 85

Secondary outcome [24]

Hemoglobin Response as a Function of Iron Status and Hepcidin

Assessment method [24]

The rate of hemoglobin level increase as a function of subject baseline iron status and hepcidin.

Timepoint [24]

Up to Day 85

Secondary outcome [25]

Hemoglobin Response as a Function of Clinical Outcome Assessment

Assessment method [25]

The rate of hemoglobin level increase as a function of the results from defined clinical outcome assessments (QoR-15 questionnaire, VAS-pain related to the surgical site, WHODAS, EQ-5D-5L, 6MWT, TUG test)

Timepoint [25]

Up to Day 85

Secondary outcome [26]

Quality of Recovery-15 (QoR-15) Questionnaire

Assessment method [26]

Change in QoR-15 Questionnaire compared to baseline. The QoR-15 questionnaire is a 15 item questionnaire used to evaluate postoperative quality of recovery in the areas of pain, physical comfort, physical independence, psychological support and emotional state. Each question is scored from 0 (very poor recovery) to 10 (excellent recovery). A higher score is considered a better outcome.

Timepoint [26]

Day 8, 15, 22, and 29

Secondary outcome [27]

Visual Analog Scale for Pain (VAS-Pain)

Assessment method [27]

Change in VAS-Pain compared to baseline. The VAS-Pain is used to assess the subject's pain at the surgical site at that moment in time. The scale is from 0 (no pain) to 10 (extreme pain). A lower score is considered a better outcome.

Timepoint [27]

Up to Day 15

Secondary outcome [28]

World Health Organization Disability Assessment Schedule (WHODAS) Questionnaire

Assessment method [28]

Change in WHODAS Questionnaire compared to baseline. The WHODAS is a general health status questionnaire designed to produce standardized disability levels by elucidating the subject's perception of health on several domains, including cognition, mobility, self-care, getting along, life activities (household and work), and participation. The questionnaire contains 36 questions that ask the subject to recall difficulty in performing activities he/she felt during the previous 30 days. The scale is from 1 (none) to 5 (extreme or cannot do). A lower score is considered a better outcome.

Timepoint [28]

Day 29, 57, and 85

Secondary outcome [29]

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

Assessment method [29]

Change in EQ-5D-5L Questionnaire compared to baseline. The EQ-5D-5L questionnaire is a 5 question tool used to assess treatment effects by measuring the gains (or losses) in subject-reported health status. The questionnaire assesses five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored on a scale from 1 (no problems) to 5 (extreme or cannot perform). A lower score is considered a better outcome.

Timepoint [29]

Day 15, 43, and 85

Secondary outcome [30]

6-minute Walk Test (6MWT) Distance

Assessment method [30]

Change in 6MWT Distance compared to baseline. Increased distance is considered a better outcome.

Timepoint [30]

Day 15, 43, and 85

Secondary outcome [31]

Timed Up and Go (TUG) Test

Assessment method [31]

Change in TUG test time compared to baseline. The TUG test is used to assess mobility and consists of the subject standing up from a chair, walking 3 meters away, turning, walking back 3 meters, and sitting down again. A shorter time is considered a better outcome.

Timepoint [31]

Day 15, 43, and 85

Secondary outcome [32]

Safety Analyses (Treatment-Emergent Adverse Events) - Incidence

Assessment method [32]

Safety analyses will be performed based on the corresponding safety set. The incidence of treatment-emergent AEs (TEAEs) will be calculated overall by system organ class, preferred term, and treatment group for each cohort and treatment group. The number and percentage of subjects with TEAEs will be further summarized by severity and relationship to the investigational product and dose level.

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

Assessment method [33]

Safety analyses will be performed based on the corresponding safety set. The number of events of treatment-emergent AEs (TEAEs) will be calculated overall by system organ class, preferred term, and treatment group for each cohort and treatment group. The number of subjects with TEAEs will be further summarized by severity and relationship to the investigational product and dose level.

Timepoint [33]

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

Secondary outcome [34]

Safety Analyses (Treatment-Emergent Adverse Events) - Percentage

Assessment method [34]

Safety analyses will be performed based on the corresponding safety set. The percentage of treatment-emergent AEs (TEAEs) will be calculated overall by system organ class, preferred term, and treatment group for each cohort and treatment group. The percentage of subjects with TEAEs will be further summarized by severity and relationship to the investigational product and dose level.

Timepoint [34]

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

Secondary outcome [35]

Safety Analyses (Adverse Events) - Individual Summary

Assessment method [35]

Adverse events related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be summarized/listed as part of the overall analysis of safety.

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

Assessment method [36]

Clinical laboratory tests (complete blood count, HemoCue, serum clinical chemistries, coagulation, serum erythropoietin levels, hemoglobin electrophoresis, inflammation panel, iron panel, folate and vitamin B12, lipid panel, thyroid, and urinalysis) findings will be summarized by treatment group and visit. Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline, if applicable. Frequency counts will be compiled for the classification of qualitative safety data. The baseline for safety data will be defined as the last value prior to the first dose of investigational product. Potentially clinically important findings will also be summarized or listed.

Timepoint [36]

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

Secondary outcome [37]

Safety Analyses (Quantitative Safety Data) - Vital Signs

Assessment method [37]

Vital signs (systolic and diastolic blood pressure and pulse rate) findings will be summarized by treatment group and visit. Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline, if applicable. Frequency counts will be compiled for the classification of qualitative safety data. The baseline for safety data will be defined as the last value prior to the first dose of investigational product. Potentially clinically important findings will also be summarized or listed.

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

Assessment method [38]

The Well's Criteria will be used to evaluate for the presence of deep vein thrombosis (DVT) and summarized by treatment group and visit. Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline, if applicable. Frequency counts will be compiled for the classification of qualitative safety data. The baseline for safety data will be defined as the last value prior to the first dose of investigational product. Potentially clinically important findings will also be summarized or listed.

Timepoint [38]

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

Secondary outcome [39]

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

Assessment method [39]

Electrocardiogram (ECG) will be performed with heart rate, PR, QRS, and QT (pre-corrected) intervals will be measured and QTcF will be calculated. ECG findings will be summarized by treatment group and visit. Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline, if applicable. Frequency counts will be compiled for the classification of qualitative safety data. The baseline for safety data will be defined as the last value prior to the first dose of investigational product. Potentially clinically important findings will also be summarized or listed.

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.

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

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

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

Trial Review

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