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A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis

NCT01999582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-24

Study results available
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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.

Conditions

  • Anemia
  • Kidney Failure, Chronic

Interventions

BIOLOGICAL

Sotatercept

Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.

BIOLOGICAL

Sotatercept

Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • William Smith, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Belgium
  • Germany
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999582 on ClinicalTrials.gov