A Phase 2 Study of Intravenous or Subcutaneous Dosing of... | NCT01999582 | Trialant
NCT01999582
Sponsor
Celgene
Status
Completed
Last Update Posted
Jun 24, 2024Actual
Enrollment
50Actual
Phase
Phase 2
Conditions
Anemia
Kidney Failure, Chronic
Interventions
Sotatercept
Sotatercept
Countries
Belgium
Germany
Portugal
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01999582
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACE-011-REN-002
Secondary IDs
ID
Type
Description
Link
2012-003788-23
EudraCT Number
Brief Title
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
Official Title
A Phase 2 Multicenter, Randomized, Open-Label , Multiple-Dose Study of Intravenous and Subcutaneous Administration of Sotatercept (ACE-011) in Subjects With End-Stage Kidney Disease on Hemodialysis Switched From Erythropoeisis Stimulating Agents With Staggered Dose Group Escalation in Part 1 Followed by a Parallel Group, Active Controlled Study of Selected Dose(s) and Regimen(s) in Part 2: To Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 30, 2013Actual
Primary Completion Date
Aug 31, 2016Actual
Completion Date
Aug 31, 2016Actual
First Submitted Date
Nov 26, 2013
First Submission Date that Met QC Criteria
Nov 26, 2013
First Posted Date
Dec 3, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 4, 2024
Results First Submitted that Met QC Criteria
Jan 4, 2024
Results First Posted Date
Jun 24, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 4, 2024
Last Update Posted Date
Jun 24, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To determine the optimal route of administration, dose level, and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis.
Detailed Description
Not provided
Conditions Module
Conditions
Anemia
Kidney Failure, Chronic
Keywords
Anemia
End Stage Kidney Disease
Chronic Kidney Disease
Dialysis
Erythrpoietin Stimulating Agent (ESA)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Intravenous Dose Group 1, 2, and 3
Experimental
Intravenous Dose Group 1 starting at 0.1 mg/kg and escalated in Dose Groups 2 (0.2 mg/kg) and Dose Group 3 (0.1, 0.2, 0.3, 0.4 mg/kg, titrated based on titration rules, administered every 14 days)
Biological: Sotatercept
Subcutaneous Dose Group 1, 2, and 3
Experimental
Subcutaneous Dose Group 1 starting at 0.13 mg/kg and escalated in Dose Groups 2 (0.26 mg/kg) and Dose Group 3 (0.4 to 0.5 mg/kg, titrated based on titration rules, administered every14 days)
Biological: Sotatercept
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sotatercept
Biological
Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
Intravenous Dose Group 1, 2, and 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days)
Area Under the plasma concentration-time curve over 14-day dosing interval (AUC14) for Sotatercept., The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d)
Area under the plasma concentration-time curve over 28-day dosing interval (AUC28d). All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d)
Maximum observed serum concentration (Cmax14d) of sotatercept, obtained directly from the observed concentration-time data. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication
The percentage of participants able to maintain a mean (Visit 14 to 17) hemoglobin concentration ≥ 100 g/L to ≤ 120 g/L without the need for rescue medication at each dose level. Mean hemoglobin value is a mean of hemoglobin concentrations from Visit 14 to Visit 17 (days 99 to 113).
Visit 14 to Visit 17 (days 99 to 113)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males or females ≥ 18 years of age.
Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening
Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta [Mircera]) to maintain hemoglobin.
A mean predialysis hemoglobin concentration ≥ 10 g/dL (grams per deciliter) to ≤ 12 g/dL (≥ 100 g/L (grams per liter) to ≤ 120 g/L) obtained from three consecutive days.
4. A Body Mass Index value ≥ 18.5 kg/m2 (kilograms per m2) at screening. 5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
6. Able to adhere to the study visit schedule and comply with all protocol requirements.
Exclusion Criteria:
Non renal causes of anemia
Subjects on peritoneal dialysis.
Systemic hematological disease
Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) > 9%) at screening.
Uncontrolled hypertension defined as mean of home systolic blood pressure > 160 mm Hg (millimeter of mercury) or mean of home diastolic blood pressure > 90 mm Hg calculated once during the screening period prior to randomization
Subjects with heart failure
History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years ago).
Anticipated or scheduled living donor renal transplant during the course of the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
William Smith, MD
Celgene Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
FG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
ACE-011
Sotatercept
Biological
Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
Subcutaneous Dose Group 1, 2, and 3
ACE-011
Maximum observed serum concentration (Cmax28d) of sotatercept, obtained directly from the observed concentration-time data combining the profiles following the first two doses. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time to maximum serum concentration (Tmax) of sotatercept, obtained directly from the observed concentration-time data. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Doses 1-2: pre- and postdose at 5 min (IV only) 4 hrs, 3, and 7 days after each dose; Doses 3-7: pre-, and postdose at 5 min after IV injection after each dose; Final dose: pre- and postdose at 5 min (IV only), 4 hrs, 3, 7, 14, 28, 56, 84, and 112 days
Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2)
Terminal elimination half-life (T1/2). The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose.
Lambda (ÊŽz): Apparent Terminal Rate Constant (at Final Dose Only)
Lambda, apparent terminal rate constant (final dose only). The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analysis of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose
Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue)
Change in mean hemoglobin concentration between baseline and Visit 14 to 17 at each dose level. Baseline hemoglobin value is the mean of three consecutive hemoglobin concentrations with the last hemoglobin concentration done within the 7 days prior to randomization and the value obtained on the day of randomization. Visit 14 to 17 hemoglobin value is a mean of hemoglobin concentrations from Day 99 [Visit 14] to Day 113 [Visit 17].
Baseline and Visit 14 to Visit 17 (days 99 to 113)
Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115)
Change in mean hemoglobin concentration between baseline and Visit 14 to 17 at each dose level for participants not rescued prior to Day 115. Baseline hemoglobin value is the mean of three consecutive hemoglobin concentrations with the last hemoglobin concentration done within the 7 days prior to randomization and the value obtained on the day of randomization. Visit 14 to 17 hemoglobin value is a mean of hemoglobin concentrations from Day 99 [Visit 14] to Day 113 [Visit 17].
Baseline and Visit 14 to Visit 17 (days 99 to 113)
Number of Participants With Adverse Events (AEs)
Treatment-emergent adverse event (TEAE) was defined as an adverse event with start date on or after date of first dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participants during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A serious adverse event is defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Severity and intensity was assessed using the following grading scale: Mild, Moderate and Severe (could be non-serious or serious).
From date of first dose of investigational product to 112 days after the last dose or until the last study visit, whichever period was longer. The maximum duration for any IV or SC dose was 114 days. Up to approximately 226 days.
Leuven
3000
Belgium
CHR de la CITADELLE
Liège
4000
Belgium
KfH Nierenzentrum Coburg
Coburg
96450
Germany
Gemeinschaftspraxis und Dialysezentrum Karlstrass
Düsseldorf
40210
Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.v.
München
80337
Germany
KfH Nierenzentrum Rosenheim
Rosenheim
83022
Germany
Nephrocare Faro
Faro
8000
Portugal
Hospital de Santa Maria
Lisbon
1649-035
Portugal
Nephrocare Portimao
Portimão
8500-311
Portugal
Complejo Hospitalario de Torrecardenas
AlmerÃa
04009
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Clinic of Barcelona
Barcelona
08036
Spain
Hospital Universitario Reina Sofia
Córdoba
14004
Spain
Hospital Galdakao-Usansolo
Galdakao
48960
Spain
Servicio de Nefrologia Hospital General Universitario Gregorio Maranon
Madrid
28007
Spain
Hospital 12 de Octubre
Madrid
28041
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid
28222
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria
39008
Spain
Hospital de Torrevieja
Torrevieja (Alicante)
03186
Spain
Cambridge University Hospitals NHS Trust
Cambridge
CB2 0QQ
United Kingdom
Glasgow Royal Infirmary
Glasgow
G11 6NT
United Kingdom
St Georges Healthcare NHS Trust
London
SW17 0QT
United Kingdom
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
FG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
FG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
FG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
FG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
FG0007 subjects
FG0017 subjects
FG0029 subjects
FG0039 subjects
FG00412 subjects
FG0056 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0036 subjects
FG00410 subjects
FG0053 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0033 subjects
FG0042 subjects
FG0053 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Other Reasons
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
BG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
BG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
BG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
BG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
BG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0017
BG0029
BG0039
BG00412
BG0056
BG00650
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.1± 15.43
BG00162.3± 13.03
BG00259.4± 15.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
BG002
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0004
BG0015
BG002
Ethnicity
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days)
Area Under the plasma concentration-time curve over 14-day dosing interval (AUC14) for Sotatercept., The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
day*ng/mL
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0004
OG0013
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00015204.31± 7096.55(7096.55 to )
OG00111269.14± 1839.92(1839.92 to )
OG00228647.03± 10332.19(10332.19 to )
Primary
Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d)
Area under the plasma concentration-time curve over 28-day dosing interval (AUC28d). All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
day*ng/mL
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Primary
Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d)
Maximum observed serum concentration (Cmax14d) of sotatercept, obtained directly from the observed concentration-time data. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
ng/mL
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Primary
Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses
Maximum observed serum concentration (Cmax28d) of sotatercept, obtained directly from the observed concentration-time data combining the profiles following the first two doses. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
ng/mL
Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Primary
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time to maximum serum concentration (Tmax) of sotatercept, obtained directly from the observed concentration-time data. The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Median
Full Range
days
Doses 1-2: pre- and postdose at 5 min (IV only) 4 hrs, 3, and 7 days after each dose; Doses 3-7: pre-, and postdose at 5 min after IV injection after each dose; Final dose: pre- and postdose at 5 min (IV only), 4 hrs, 3, 7, 14, 28, 56, 84, and 112 days
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Primary
Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2)
Terminal elimination half-life (T1/2). The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analyses of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
days
Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose.
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Primary
Lambda (ÊŽz): Apparent Terminal Rate Constant (at Final Dose Only)
Lambda, apparent terminal rate constant (final dose only). The PK population included all participants in the safety population with at least one non-missing plasma concentration data. All analysis of PK data were based on the PK population and participants were analyzed according to the treatment group to which they were randomized.
Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint
Posted
Mean
Standard Deviation
1/day
Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Secondary
Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication
The percentage of participants able to maintain a mean (Visit 14 to 17) hemoglobin concentration ≥ 100 g/L to ≤ 120 g/L without the need for rescue medication at each dose level. Mean hemoglobin value is a mean of hemoglobin concentrations from Visit 14 to Visit 17 (days 99 to 113).
All randomized participants
Posted
Number
Percentage of participants
Visit 14 to Visit 17 (days 99 to 113)
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Secondary
Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue)
Change in mean hemoglobin concentration between baseline and Visit 14 to 17 at each dose level. Baseline hemoglobin value is the mean of three consecutive hemoglobin concentrations with the last hemoglobin concentration done within the 7 days prior to randomization and the value obtained on the day of randomization. Visit 14 to 17 hemoglobin value is a mean of hemoglobin concentrations from Day 99 [Visit 14] to Day 113 [Visit 17].
All randomized participants who received at least one dose of treatment.
Posted
Mean
Standard Deviation
g/L
Baseline and Visit 14 to Visit 17 (days 99 to 113)
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Secondary
Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115)
Change in mean hemoglobin concentration between baseline and Visit 14 to 17 at each dose level for participants not rescued prior to Day 115. Baseline hemoglobin value is the mean of three consecutive hemoglobin concentrations with the last hemoglobin concentration done within the 7 days prior to randomization and the value obtained on the day of randomization. Visit 14 to 17 hemoglobin value is a mean of hemoglobin concentrations from Day 99 [Visit 14] to Day 113 [Visit 17].
All randomized participants who received at least one dose of treatment and were not rescued prior to Day 115.
Posted
Mean
Standard Deviation
g/L
Baseline and Visit 14 to Visit 17 (days 99 to 113)
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Secondary
Number of Participants With Adverse Events (AEs)
Treatment-emergent adverse event (TEAE) was defined as an adverse event with start date on or after date of first dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participants during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A serious adverse event is defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Severity and intensity was assessed using the following grading scale: Mild, Moderate and Severe (could be non-serious or serious).
All randomized participants
Posted
Count of Participants
Participants
From date of first dose of investigational product to 112 days after the last dose or until the last study visit, whichever period was longer. The maximum duration for any IV or SC dose was 114 days. Up to approximately 226 days.
ID
Title
Description
OG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
OG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Time Frame
All-cause mortality was assessed from date of first dose to study completion (up to approximately 33 months). Serious Adverse events and other adverse events were assessed from date of first dose to 112 days after the last dose or until the last study visit, whichever period was longer, up to approximately 226 days.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection
Participants received sotatercept at 0.1 mg/kg administered IV every 14 days for up to 8 doses to evaluate the Pharmacokinetic (PK) and safety of IV versus subcutaneous (SQ) dosing of sotatercept.
0
7
3
7
7
7
EG001
Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
0
7
0
7
3
7
EG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
0
9
3
9
9
9
EG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
0
9
1
9
6
9
EG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
0
12
3
12
9
12
EG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
1
6
3
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected6 at risk
Cardiac failure
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Gastrointestinal angiodysplasia haemorrhagic
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Device related infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Paronychia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Arteriovenous graft site stenosis
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Shunt thrombosis
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Vascular access malfunction
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected6 at risk
Angina pectoris
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Hyperparathyroidism secondary
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Amaurosis
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Amaurosis fugax
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Choroidal effusion
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Catheter site pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Face oedema
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Malaise
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0004 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Localised infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected9 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Arteriovenous fistula site haematoma
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Arteriovenous fistula site haemorrhage
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Haemodialysis-induced symptom
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Cardioactive drug level increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Calciphylaxis
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Juvenile melanoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Respiratory acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Extravasation blood
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Extremity necrosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0013 events1 affected7 at risk
EG0023 events1 affected9 at risk
EG003
Pallor
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected9 at risk
EG003
Due to a shift in the clinical development strategy for the renal sotatercept program, Part 2 of the study was not conducted; Part 2 objectives were not assessed and none of the statistical analyses in Part 2 were conducted; no safety concerns.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Please email
Clinical.Trials@bms.com
ID
Term
D000740
Anemia
D007676
Kidney Failure, Chronic
D051436
Renal Insufficiency, Chronic
Ancestor Terms
ID
Term
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D051437
Renal Insufficiency
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C542017
ACE-011
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
1 subjects
FG0052 subjects
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
61.9
± 15.43
BG00461.4± 15.68
BG00553.7± 15.93
BG00660.0± 14.75
4
BG0033
BG0045
BG0053
BG00622
Male
BG0003
BG0014
BG0025
BG0036
BG0047
BG0053
BG00628
6
BG0038
BG00411
BG0056
BG00640
Black or African- American
BG0001
BG0011
BG0021
BG0030
BG0041
BG0050
BG0064
Asian
BG0002
BG0010
BG0022
BG0031
BG0040
BG0050
BG0065
American Indian/Alaska Native
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
1
BG0030
BG0040
BG0050
BG0062
Not Hispanic or Latino
BG0007
BG0016
BG0028
BG0039
BG00412
BG0056
BG00648
6
OG0047
OG0055
OG00310327.98± 8065.12(8065.12 to )
OG00415886.83± 4212.12(4212.12 to )
OG00521982.9± 5125.4(5125.4 to )
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
OG0045
OG0052
Title
Denominators
Categories
Title
Measurements
OG00038361.5± 8589.34(8589.34 to )
OG00141500.36± 13647.28(13647.28 to )
OG00294106.54± 37204.17(37204.17 to )
OG00336065.09± 22817(22817 to )
OG00433173.4± 8709.16(8709.16 to )
OG00560497.8± 14623.13(14623.13 to )
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0004
OG0013
OG0028
OG0036
OG0047
OG0055
Title
Denominators
Categories
Title
Measurements
OG0002567.6± 1093.73(1093.73 to )
OG0011024.27± 145.8(145.8 to )
OG0024623.61± 1620.66(1620.66 to )
OG003963.05± 659.65(659.65 to )
OG0043155.53± 1861.07(1861.07 to )
OG0051993.58± 375.54(375.54 to )
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
OG0045
OG0052
Title
Denominators
Categories
Title
Measurements
OG0003557.93± 699.19(699.19 to )
OG0013868.83± 3614.89(3614.89 to )
OG0028613.67± 3559.69(3559.69 to )
OG0031967.55± 1128.69(1128.69 to )
OG0043501.54± 2144.15(2144.15 to )
OG0053161.6± 788.14(788.14 to )
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0034
OG0045
OG0052
Title
Denominators
Categories
Title
Measurements
OG00014.09± 14.01(14.01 to 16)
OG00121.01± 16.16(16.16 to 27.98)
OG00214.02± 13.99(13.99 to 16.01)
OG00318.51± 15.99(15.99 to 21.02)
OG0040.1688± 0.0035(0.0035 to 15.99)
OG00521.06± 20.99(20.99 to 21.13)
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0038
OG0049
OG0054
Title
Denominators
Categories
Title
Measurements
OG00017.6± 4.631(4.631 to )
OG00125.87± 7.127(7.127 to )
OG00221.76± 3.941(3.941 to )
OG00321.03± 5.4(5.4 to )
OG00422.46± 5.342(5.342 to )
OG00520.39± 5.3(5.3 to )
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0038
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.0414± 0.0094(0.0094 to )
OG0010.0282± 0.0071(0.0071 to )
OG0020.0328± 0.0063(0.0063 to )
OG0030.0346± 0.0078(0.0078 to )
OG0040.0326± 0.0085(0.0085 to )
OG0050.0355± 0.0077(0.0077 to )
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0007
OG0017
OG0029
OG0039
OG00412
OG0056
Title
Denominators
Categories
Title
Measurements
OG00042.9
OG00142.9
OG00211.1
OG00333.3
OG00425
OG00550
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0007
OG0015
OG0025
OG0037
OG0049
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-6.9± 11.61(11.61 to )
OG001-2.7± 6.47(6.47 to )
OG002-2.1± 12.23(12.23 to )
OG003-0.8± 10.03(10.03 to )
OG004-9.9± 9.3(9.3 to )
OG005-6.4± 12.6(12.6 to )
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
Units
Counts
Participants
OG0003
OG0014
OG0022
OG0036
OG0046
OG0053
Title
Denominators
Categories
Title
Measurements
OG000-7± 6.24(6.24 to )
OG001-3.6± 7.08(7.08 to )
OG002-0.3± 15.2(15.2 to )
OG0030.5± 10.28(10.28 to )
OG004-13± 10.07(10.07 to )
OG005-1± 8.05(8.05 to )
Participants received sotatercept at 0.13 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG002
Group 2: Sotatercept 0.2 mg/kg IV Injection
Participants received sotatercept at 0.2 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG003
Group 2: Sotatercept 0.26 mg/kg SC Injection
Participants received sotatercept at 0.26 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG004
Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection
Participants received sotatercept at a starting dose of 0.1 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.4 mg/kg administered IV every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.
OG005
Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection
Participants received sotatercept at 0.4 mg/kg. Intra subject dose escalation will be implemented in response to subjects' individual hemoglobin levels and can be increased in 0.1 mg/kg increments up to 0.5 mg/kg administered SC every 14 days for up to 8 doses to evaluate the PK and safety of IV versus SC dosing of sotatercept.