Trial · NCT01146574
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.
NCT01146574, Phase 2, Completed, Celgene; results first posted 2024-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01146574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01146574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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.
- NCT number
- NCT01146574
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Anemia
- Interventions
- Sotatercept, Placebo
- First posted
- 2010-06-17
- Last updated
- 2024-03-01
- Results first posted
- 2024-03-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Observed Maximum Concentration (Cmax) | 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. |
| Primary | Time to Maximum Concentration (Tmax) | 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. |
| Primary | Area Under Curve (AUC)-28 Days | 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 |
| Primary | AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity | 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. |
| Primary | Apparent Total Clearance (CL/F) | 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. |
| Primary | Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | 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. |
| Primary | Terminal Half-Life (t1/2,z) | 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. |
| Secondary | The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 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. |
| Secondary | Number of Participants With Hemoglobin > 12g/dL | 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. |
| Secondary | Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Observed Maximum Concentration (Cmax) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug/mL | MEAN |
| PRIMARY | Time to Maximum Concentration (Tmax) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Days | MEDIAN |
| PRIMARY | Area Under Curve (AUC)-28 Days | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug·day/mL | MEAN |
| PRIMARY | AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity | From first dose up to Day 28 | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug·day/mL | MEAN |
| PRIMARY | Apparent Total Clearance (CL/F) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | L/day | MEAN |
| PRIMARY | Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | From first dose up to Day 28 | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | mL/kg | MEAN |
| PRIMARY | Terminal Half-Life (t1/2,z) | Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Day | MEAN |
| SECONDARY | The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | From first dose up to 115 days post last dose | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hemoglobin > 12g/dL | 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 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period | 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 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Observed Maximum Concentration (Cmax) | Part 1-ACE-011 0.1 mg/kg | 1.022 | Standard Deviation 0.576 | ug/mL | |
| Observed Maximum Concentration (Cmax) | Part 2-0.3 mg/kg | 2.40 | Standard Deviation 0.96 | ug/mL | |
| Observed Maximum Concentration (Cmax) | Part 2-0.5 mg/kg | 3.66 | Standard Deviation 0.67 | ug/mL | |
| Observed Maximum Concentration (Cmax) | Part 2-0.7 mg/kg | 3.97 | Standard Deviation 1.64 | ug/mL | |
| Observed Maximum Concentration (Cmax) | Part 2-0.7/0.4 mg/kg | 7.71 | Standard Deviation 1.97 | ug/mL | |
| Time to Maximum Concentration (Tmax) | Part 1-ACE-011 0.1 mg/kg | 6 | Full Range 3 to 14 | Days | |
| Time to Maximum Concentration (Tmax) | Part 2-0.3 mg/kg | 7 | Full Range 3 to 14 | Days | |
| Time to Maximum Concentration (Tmax) | Part 2-0.5 mg/kg | 8 | Full Range 4 to 12 | Days | |
| Time to Maximum Concentration (Tmax) | Part 2-0.7 mg/kg | 7 | Full Range 4 to 10 | Days | |
| Time to Maximum Concentration (Tmax) | Part 2-0.7/0.4 mg/kg | 5 | Full Range 3 to 13 | Days |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1-Placebo | 1 | |
| Overall Study | STARTED | Part 1-ACE-011 0.1 mg/kg | 6 | |
| Overall Study | STARTED | Part 2- Placebo | 11 | |
| Overall Study | STARTED | Part 2-0.3 mg/kg | 9 | |
| Overall Study | STARTED | Part 2-0.5 mg/kg | 8 | |
| Overall Study | STARTED | Part 2-0.7 mg/kg | 9 | |
| Overall Study | STARTED | Part 2-0.7/0.4 mg/kg | 6 | |
| Overall Study | COMPLETED | Part 1-Placebo | 1 | |
| Overall Study | COMPLETED | Part 1-ACE-011 0.1 mg/kg | 5 | |
| Overall Study | COMPLETED | Part 2- Placebo | 5 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events973
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 1 - Placebo | 0 | 1 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 1 - ACE-011 0.1 mg/kg | 0 | 6 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 2 - Placebo | 1 | 11 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 2 - 0.3 mg/kg | 0 | 9 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 2 - 0.5 mg/kg | 0 | 8 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 2 - 0.7 mg/kg | 0 | 9 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Part 2 - 0.7/0.4 mg/kg | 0 | 6 | |
| other | ANGINA UNSTABLE | Cardiac disorders | Part 1 - Placebo | 0 | 1 | |
| other | ANGINA UNSTABLE | Cardiac disorders | Part 1 - ACE-011 0.1 mg/kg | 0 | 6 | |
| other | ANGINA UNSTABLE | Cardiac disorders | Part 2 - Placebo | 1 | 11 |
1 to 10 of 973Source ClinicalTrials.gov
See all 973 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 - Placebo | 0 | 1 |
| Total, all-cause mortality | Part 1 - ACE-011 0.1 mg/kg | 1 | 6 |
| Total, all-cause mortality | Part 2 - Placebo | 2 | 11 |
| Total, all-cause mortality | Part 2 - 0.3 mg/kg | 0 | 9 |
| Total, all-cause mortality | Part 2 - 0.5 mg/kg | 0 | 8 |
| Total, all-cause mortality | Part 2 - 0.7 mg/kg | 0 | 9 |
| Total, all-cause mortality | Part 2 - 0.7/0.4 mg/kg | 0 | 6 |
| Total, other adverse events | Part 1 - Placebo | 1 | 1 |
| Total, other adverse events | Part 1 - ACE-011 0.1 mg/kg | 6 | 6 |
| Total, other adverse events | Part 2 - Placebo | 6 | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01146574
GET https://conductscience.org/api/trials/v1/NCT01146574/results?page=2