Trial · NCT01999582
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
NCT01999582, Phase 2, Completed, Celgene; results first posted 2024-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis. Trials, record NCT01999582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
- NCT number
- NCT01999582
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Anemia, Kidney Failure, Chronic
- Interventions
- Sotatercept, Sotatercept
- First posted
- 2013-12-03
- Last updated
- 2024-06-24
- Other registries' IDs
- eudract:2012-003788-23
- Results first posted
- 2024-06-24
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | 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 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. |
| Primary | Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | 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 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. |
| Primary | Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d) | 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 (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. |
| Primary | Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses | 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) 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. |
| Primary | Time to Reach Maximum Observed Serum Concentration (Tmax) | 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 | 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. |
| Primary | Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose. | 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. |
| Primary | Lambda (ʎz): Apparent Terminal Rate Constant (at Final Dose Only) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose | 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. |
| Secondary | Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication | Visit 14 to Visit 17 (days 99 to 113) | 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). |
| Secondary | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | 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 \[Visit 17\]. |
| Secondary | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | 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 \[Visit 17\]. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | 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 | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | day*ng/mL | MEAN |
| PRIMARY | Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | 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 | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | day*ng/mL | MEAN |
| PRIMARY | Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d) | 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 | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | ng/mL | MEAN |
| PRIMARY | Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses | 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 | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | ng/mL | MEAN |
| PRIMARY | Time to Reach Maximum Observed Serum Concentration (Tmax) | 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 | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | days | MEDIAN |
| PRIMARY | Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose. | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | days | MEAN |
| PRIMARY | Lambda (ʎz): Apparent Terminal Rate Constant (at Final Dose Only) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | 1/day | MEAN |
| SECONDARY | Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication | Visit 14 to Visit 17 (days 99 to 113) | All randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | All randomized participants who received at least one dose of treatment. | g/L | MEAN |
| SECONDARY | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | All randomized participants who received at least one dose of treatment and were not rescued prior to Day 115. | g/L | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 15204.31 | Standard Deviation 7096.55 | day*ng/mL | |
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 11269.14 | Standard Deviation 1839.92 | day*ng/mL | |
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 2: Sotatercept 0.2 mg/kg IV Injection | 28647.03 | Standard Deviation 10332.19 | day*ng/mL | |
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 2: Sotatercept 0.26 mg/kg SC Injection | 10327.98 | Standard Deviation 8065.12 | day*ng/mL | |
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection | 15886.83 | Standard Deviation 4212.12 | day*ng/mL | |
| Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection | 21982.9 | Standard Deviation 5125.4 | day*ng/mL | |
| Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 38361.5 | Standard Deviation 8589.34 | day*ng/mL | |
| Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 41500.36 | Standard Deviation 13647.28 | day*ng/mL | |
| Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | Group 2: Sotatercept 0.2 mg/kg IV Injection | 94106.54 | Standard Deviation 37204.17 | day*ng/mL | |
| Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | Group 2: Sotatercept 0.26 mg/kg SC Injection | 36065.09 | Standard Deviation 22817 | day*ng/mL |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 7 | |
| Overall Study | STARTED | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 7 | |
| Overall Study | STARTED | Group 2: Sotatercept 0.2 mg/kg IV Injection | 9 | |
| Overall Study | STARTED | Group 2: Sotatercept 0.26 mg/kg SC Injection | 9 | |
| Overall Study | STARTED | Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection | 12 | |
| Overall Study | STARTED | Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection | 6 | |
| Overall Study | COMPLETED | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 4 | |
| Overall Study | COMPLETED | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 4 | |
| Overall Study | COMPLETED | Group 2: Sotatercept 0.2 mg/kg IV Injection | 3 | |
| Overall Study | COMPLETED | Group 2: Sotatercept 0.26 mg/kg SC Injection | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events624
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 | Pancytopenia | Blood and lymphatic system disorders | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 0 | 7 | 0 |
| other | Pancytopenia | Blood and lymphatic system disorders | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 0 | 7 | 0 |
| other | Pancytopenia | Blood and lymphatic system disorders | Group 2: Sotatercept 0.2 mg/kg IV Injection | 1 | 9 | 1 |
| other | Pancytopenia | Blood and lymphatic system disorders | Group 2: Sotatercept 0.26 mg/kg SC Injection | 0 | 9 | 0 |
| other | Pancytopenia | Blood and lymphatic system disorders | Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection | 0 | 12 | 0 |
| other | Pancytopenia | Blood and lymphatic system disorders | Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection | 0 | 6 | 0 |
| other | Angina pectoris | Cardiac disorders | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 1 | 7 | 1 |
| other | Angina pectoris | Cardiac disorders | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 0 | 7 | 0 |
| other | Angina pectoris | Cardiac disorders | Group 2: Sotatercept 0.2 mg/kg IV Injection | 0 | 9 | 0 |
| other | Angina pectoris | Cardiac disorders | Group 2: Sotatercept 0.26 mg/kg SC Injection | 0 | 9 | 0 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 0 | 7 |
| Total, all-cause mortality | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 0 | 7 |
| Total, all-cause mortality | Group 2: Sotatercept 0.2 mg/kg IV Injection | 0 | 9 |
| Total, all-cause mortality | Group 2: Sotatercept 0.26 mg/kg SC Injection | 0 | 9 |
| Total, all-cause mortality | Group 3: Sotatercept 0.1 - 0.4 mg/kg IV Injection | 0 | 12 |
| Total, all-cause mortality | Group 3: Sotatercept 0.4 - 0.5 mg/kg SC Injection | 1 | 6 |
| Total, other adverse events | Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection | 7 | 7 |
| Total, other adverse events | Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection | 3 | 7 |
| Total, other adverse events | Group 2: Sotatercept 0.2 mg/kg IV Injection | 9 | 9 |
| Total, other adverse events | Group 2: Sotatercept 0.26 mg/kg SC Injection | 6 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
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