Completed PHASE2 INTERVENTIONAL 5-arm 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.

A Phase 2a, Multi-center, Randomized, Single Dose, Double-blind, Placebo-controlled Followed by a Multiple-dose, Single-blind, Placebo-controlled, Dose Escalation 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 (ESRD) on Hemodialysis (HD).

Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Conditions Anemia

Interventions Placebo Sotatercept

Updated 13 times since 2017 Last updated: Feb 2, 2024 Started: Jun 30, 2010 Primary completion: Mar 7, 2016 Completion: Mar 7, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Anemia, this trial is completed. The trial is conducted by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA and has accumulated 13 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

13 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2024 — Jul 2024 [monthly]

Completed PHASE2
Jun 2023 — Apr 2024 [monthly]

Completed PHASE2

▶ Show 8 earlier versions

Nov 2022 — Jun 2023 [monthly]

Completed PHASE2
Apr 2022 — Nov 2022 [monthly]

Completed PHASE2
Oct 2021 — Apr 2022 [monthly]

Completed PHASE2
Jan 2021 — Oct 2021 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Mar 2017 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Mar 2017 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jun 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Celgene

Data source: Celgene

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Azusa, United States , Bethlehem, United States , Charlottesville, United States , Cleveland, United States , Glendale, United States , Houston, United States , Kalamazoo, United States , La Mesa, United States , Las Vegas, United States , Lexington, United States and 9 more locations