NCT01146574 is a Phase 2 clinical trial of Sotatercept in Anemia, sponsored by Celgene.

Who is sponsoring NCT01146574?

NCT01146574 is sponsored by Celgene.

What drugs are being tested in NCT01146574?

Interventions in NCT01146574: Sotatercept, Placebo.

Is NCT01146574 still recruiting?

NCT01146574 is currently completed. Last updated 1 March 2024.

Are results published for NCT01146574?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-01 · How we verify

NCT01146574

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.

Completed Phase 2 Results posted Last updated 1 March 2024

What this trial tests

Phase 2 trial testing Sotatercept in Anemia in 50 participants. Completed in 7 March 2016.

Timeline

30 June 2010

Primary endpoint
7 March 2016

7 March 2016

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	30 June 2010
Primary completion	7 March 2016
Estimated completion	7 March 2016
Sites	24 locations across United States

Drugs / interventions tested

Sotatercept (SOTATERCEPT) — full drug profile →
Placebo

Conditions studied

Anemia — all drugs for Anemia →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Observed Maximum Concentration (Cmax) Primary · From first dose up to Day 28

Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	1.022	± 0.576
Part 2-0.3 mg/kg	2.40	± 0.96
Part 2-0.5 mg/kg	3.66	± 0.67
Part 2-0.7 mg/kg	3.97	± 1.64
Part 2-0.7/0.4 mg/kg	7.71	± 1.97

Time to Maximum Concentration (Tmax) Primary · From first dose up to Day 28

Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	6	3 – 14
Part 2-0.3 mg/kg	7	3 – 14
Part 2-0.5 mg/kg	8	4 – 12
Part 2-0.7 mg/kg	7	4 – 10
Part 2-0.7/0.4 mg/kg	5	3 – 13

Area Under Curve (AUC)-28 Days Primary · From first dose up to Day 28

AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	20.6	± 11.4
Part 2-0.3 mg/kg	50.64	± 17.67
Part 2-0.5 mg/kg	78.03	± 13.34
Part 2-0.7 mg/kg	87.51	± 36.68
Part 2-0.7/0.4 mg/kg	126.96	± 20.75

AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity Primary · From first dose up to Day 28

Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	35.8	± 17.4

Apparent Total Clearance (CL/F) Primary · From first dose up to Day 28

Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	3.22	± 1.20
Part 2-0.3 mg/kg	0.255	± 0.068
Part 2-0.5 mg/kg	0.261	± 0.075
Part 2-0.7 mg/kg	0.532	± 0.654
Part 2-0.7/0.4 mg/kg	0.298	± 0.112

Apparent Volume of Distribution Based on Terminal Phase (Vz/F) Primary · From first dose up to Day 28

Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	98	± 38

Terminal Half-Life (t1/2,z) Primary · Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113

Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.

Group	Value	95% CI
Part 1-ACE-011 0.1 mg/kg	21.1	± 3.9
Part 2-0.3 mg/kg	24.3	± 3.28
Part 2-0.5 mg/kg	32.1	± 19.9
Part 2-0.7 mg/kg	22.2	± 7.00
Part 2-0.7/0.4 mg/kg	19.6	± 2.91

The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Secondary · From first dose up to 115 days post last dose

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Group	Value	95% CI
Part 1-Placebo	1
Part 1-ACE-011 0.1 mg/kg	6
Part 2- Placebo	7
Part 2-0.3 mg/kg	8
Part 2-0.5 mg/kg	6
Part 2-0.7 mg/kg	8
Part 2-0.7/0.4 mg/kg	4

Number of Participants With Hemoglobin > 12g/dL Secondary · Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Number of participants with hemoglobin \> 12g/dL including Hb values obtained after first study drug dose and before any rescue.

Group	Value	95% CI
Part 1-Placebo	0
Part 1-ACE-011 0.1 mg/kg	0
Part 2- Placebo	0
Part 2-0.3 mg/kg	0
Part 2-0.5 mg/kg	0
Part 2-0.7 mg/kg	1
Part 2-0.7/0.4 mg/kg	0

Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period Secondary · Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Proportion of participants with rise in hemoglobin (Hb) \> 2 g/dL during a 4-week period including Hb values obtained after first study drug dose and before any rescue.

Group	Value	95% CI
Part 1-Placebo	0
Part 1-ACE-011 0.1 mg/kg	0
Part 2- Placebo	0
Part 2-0.3 mg/kg	0
Part 2-0.5 mg/kg	1
Part 2-0.7 mg/kg	0
Part 2-0.7/0.4 mg/kg	0

Blood Pressure Changes From Baseline Secondary · From pre-dose up to the final visit 112 days after last dose (up to 225 days)

Blood pressure was generally recorded on the day of dialysis and represent pre-dialysis values. Baseline is defined as blood pressure measurements recorded on Day 1 of the first dose administered.

Systolic Blood Pressure Baseline Day 1

Group	Value	95% CI
Part 1-Placebo	151.0	± NA
Part 1-ACE-011 0.1 mg/kg	142.8	± 13.11
Part 2- Placebo	129.4	± 27.99
Part 2-0.3 mg/kg	145.9	± 9.75
Part 2-0.5 mg/kg	141.4	± 18.72
Part 2-0.7 mg/kg	139.9	± 29.25
Part 2-0.7/0.4 mg/kg	135.0	± 25.09

Systolic Blood Pressure Final Visit

Group	Value	95% CI
Part 1-Placebo	163.0	± NA
Part 1-ACE-011 0.1 mg/kg	134.6	± 6.95
Part 2- Placebo	145.0	± 26.91
Part 2-0.3 mg/kg	167.0	± 12.81
Part 2-0.5 mg/kg	154.0	± 34.47
Part 2-0.7 mg/kg	154.3	± 22.93
Part 2-0.7/0.4 mg/kg	131.8	± 12.79

Diastolic Blood Pressure Baseline Day 1

Group	Value	95% CI
Part 1-Placebo	75.0	± NA
Part 1-ACE-011 0.1 mg/kg	81.5	± 7.56
Part 2- Placebo	71.6	± 13.42
Part 2-0.3 mg/kg	78.2	± 12.45
Part 2-0.5 mg/kg	74.3	± 8.41
Part 2-0.7 mg/kg	64.6	± 13.33
Part 2-0.7/0.4 mg/kg	72.0	± 16.10

Diastolic Blood Pressure Final Visit

Group	Value	95% CI
Part 1-Placebo	83.0	± NA
Part 1-ACE-011 0.1 mg/kg	86.2	± 15.93
Part 2- Placebo	79.7	± 15.53
Part 2-0.3 mg/kg	85.2	± 9.83
Part 2-0.5 mg/kg	83.6	± 18.98
Part 2-0.7 mg/kg	75.3	± 9.19
Part 2-0.7/0.4 mg/kg	71.6	± 10.01

Changes in Follicle Stimulating Hormone (FSH) Secondary · Day 1 (baseline), Day 15, Day 29, and Day 113

The change in follicle stimulating measured at pre-specified timepoints throughout the treatment period.

Day 1 (baseline)

Group	Value	95% CI
Part 1-Placebo	23.5	± NA
Part 1-ACE-011 0.1 mg/kg	36.9	± 67.65

Day 15

Group	Value	95% CI
Part 1-Placebo	17.1	± NA
Part 1-ACE-011 0.1 mg/kg	51.8	± 80.76

Day 29

Group	Value	95% CI
Part 1-Placebo	17.5	± NA
Part 1-ACE-011 0.1 mg/kg	37.4	± 67.69

Day 113

Group	Value	95% CI
Part 1-Placebo	11.8	± NA
Part 1-ACE-011 0.1 mg/kg	48.2	± 78.81

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 - Placebo

Serious: 0/1 (0%)

Deaths: 0/1

Part 1 - ACE-011 0.1 mg/kg

Serious: 2/6 (33%)

Deaths: 1/6

Part 2 - Placebo

Serious: 3/11 (27%)

Deaths: 2/11

Part 2 - 0.3 mg/kg

Serious: 4/9 (44%)

Deaths: 0/9

Part 2 - 0.5 mg/kg

Serious: 0/8 (0%)

Deaths: 0/8

Part 2 - 0.7 mg/kg

Serious: 5/9 (56%)

Deaths: 0/9

Part 2 - 0.7/0.4 mg/kg

Serious: 1/6 (17%)

Deaths: 0/6

Serious adverse events (34 terms)

Reaction	System	Part 1 - Placebo	Part 1 - ACE-011 0.1 mg/kg	Part 2 - Placebo	Part 2 - 0.3 mg/kg	Part 2 - 0.5 mg/kg	Part 2 - 0.7 mg/kg	Part 2 - 0.7/0.4 mg/kg
ANGINA PECTORIS	Cardiac disorders	—	—	—	—	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	—	—	—	—	—	—	—
ANGINA UNSTABLE	Cardiac disorders	—	—	—	—	—	—	—
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	—	—	—	—	—	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—	—	—	—	—	—
CARDIOMYOPATHY	Cardiac disorders	—	—	—	—	—	—	—
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	—	—	—	—	—	—	—
ILEUS	Gastrointestinal disorders	—	—	—	—	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—
GAIT DISTURBANCE	General disorders	—	—	—	—	—	—	—
NON-CARDIAC CHEST PAIN	General disorders	—	—	—	—	—	—	—
OEDEMA PERIPHERAL	General disorders	—	—	—	—	—	—	—
GASTROENTERITIS	Infections and infestations	—	—	—	—	—	—	—
OESOPHAGEAL CANDIDIASIS	Infections and infestations	—	—	—	—	—	—	—
PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—
PNEUMONIA BACTERIAL	Infections and infestations	—	—	—	—	—	—	—
TRACHEOBRONCHITIS	Infections and infestations	—	—	—	—	—	—	—
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
FALL	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
HEART RATE IRREGULAR	Investigations	—	—	—	—	—	—	—
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	—	—	—	—	—	—	—
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
TUMOUR THROMBOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—

Other adverse events (105 terms — click to expand)

Reaction	System	Part 1 - Placebo	Part 1 - ACE-011 0.1 mg/kg	Part 2 - Placebo	Part 2 - 0.3 mg/kg	Part 2 - 0.5 mg/kg	Part 2 - 0.7 mg/kg	Part 2 - 0.7/0.4 mg/kg
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—
HYPERTENSION	Vascular disorders	—	—	—	—	—	—	—
CONSTIPATION	Gastrointestinal disorders	—	—	—	—	—	—	—
FATIGUE	General disorders	—	—	—	—	—	—	—
PAIN	General disorders	—	—	—	—	—	—	—
ARTERIOVENOUS FISTULA SITE COMPLICATION	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
BLOOD PHOSPHORUS INCREASED	Investigations	—	—	—	—	—	—	—
DIZZINESS	Nervous system disorders	—	—	—	—	—	—	—
HYPOTENSION	Vascular disorders	—	—	—	—	—	—	—
LYMPHADENOPATHY	Blood and lymphatic system disorders	—	—	—	—	—	—	—
ANGINA UNSTABLE	Cardiac disorders	—	—	—	—	—	—	—
CORONARY ARTERY DISEASE	Cardiac disorders	—	—	—	—	—	—	—
RETINAL DETACHMENT	Eye disorders	—	—	—	—	—	—	—
VITREOUS HAEMORRHAGE	Eye disorders	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—	—	—	—	—	—	—
OESOPHAGITIS	Gastrointestinal disorders	—	—	—	—	—	—	—
RECTAL HAEMORRHAGE	Gastrointestinal disorders	—	—	—	—	—	—	—
TOOTHACHE	Gastrointestinal disorders	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—
ASTHENIA	General disorders	—	—	—	—	—	—	—
MEDICAL DEVICE COMPLICATION	General disorders	—	—	—	—	—	—	—
OEDEMA	General disorders	—	—	—	—	—	—	—
OEDEMA PERIPHERAL	General disorders	—	—	—	—	—	—	—
ACARODERMATITIS	Infections and infestations	—	—	—	—	—	—	—
ARTERIOVENOUS FISTULA SITE INFECTION	Infections and infestations	—	—	—	—	—	—	—
BACTERAEMIA	Infections and infestations	—	—	—	—	—	—	—
BRONCHITIS	Infections and infestations	—	—	—	—	—	—	—
CELLULITIS	Infections and infestations	—	—	—	—	—	—	—
CORNEAL INFECTION	Infections and infestations	—	—	—	—	—	—	—
FOLLICULITIS	Infections and infestations	—	—	—	—	—	—	—
GASTROENTERITIS VIRAL	Infections and infestations	—	—	—	—	—	—	—
OTITIS MEDIA	Infections and infestations	—	—	—	—	—	—	—
SINUSITIS	Infections and infestations	—	—	—	—	—	—	—
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	—	—	—	—	—	—	—
TOOTH INFECTION	Infections and infestations	—	—	—	—	—	—	—
TRACHEOBRONCHITIS	Infections and infestations	—	—	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—
VIRAL INFECTION	Infections and infestations	—	—	—	—	—	—	—

Most-reported serious reactions: ANGINA PECTORIS, ANAEMIA, ACUTE MYOCARDIAL INFARCTION, ANGINA UNSTABLE, ARTERIOSCLEROSIS CORONARY ARTERY, ATRIAL FIBRILLATION, CARDIOMYOPATHY, GASTROINTESTINAL HAEMORRHAGE.

Data from ClinicalTrials.gov NCT01146574 adverse events section.

Sponsor's own description

This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical development of galunisertib (LY2157299 monohydrate), a small molecule inhibitor of transforming growth factor-beta signaling pathway.
Herbertz S, Sawyer JS, Stauber AJ, Gueorguieva I, et al · · 2015 · cited 424× · PMID 26309397 · DOI 10.2147/dddt.s86621
Ligand trap for the activin type IIA receptor protects against vascular disease and renal fibrosis in mice with chronic kidney disease.
Agapova OA, Fang Y, Sugatani T, Seifert ME, et al · · 2016 · cited 66× · PMID 27165838 · DOI 10.1016/j.kint.2016.02.002
Sotatercept Safety and Effects on Hemoglobin, Bone, and Vascular Calcification.
Coyne DW, Singh HN, Smith WT, Giuseppi AC, et al · · 2019 · cited 25× · PMID 31891000 · DOI 10.1016/j.ekir.2019.08.001
New Biomarkers of Ferric Management in Multiple Myeloma and Kidney Disease-Associated Anemia.
Banaszkiewicz M, Małyszko J, Vesole DH, Woziwodzka K, et al · · 2019 · cited 15× · PMID 31683939 · DOI 10.3390/jcm8111828

Verify or expand the search:

Other trials of Sotatercept

Trials testing the same drug.

NCT07498803 — Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome · Phase 2 · not yet recruiting
NCT07356778 — A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hyperten · Phase 4 · recruiting
NCT07140484 — Sotatercept in Pulmonary Arterial Hypertension · Phase 4 · recruiting
NCT06930664 — A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the L · Phase 1 · completed
NCT06658522 — Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effec · Phase 4 · recruiting

Other recruiting trials for Anemia

Currently open trials in the same condition.

NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01146574 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 1 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01146574.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing