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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999582
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Kidney Failure, Chronic Biological: Sotatercept Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Open-Label , Multiple-Dose Study of Intravenous and Subcutaneous Administration of Sotatercept (ACE-011) in Subjects With End-Stage Kidney Disease on Hemodialysis Switched From Erythropoeisis Stimulating Agents With Staggered Dose Group Escalation in Part 1 Followed by a Parallel Group, Active Controlled Study of Selected Dose(s) and Regimen(s) in Part 2: To Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept
Study Start Date : November 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous Dose Group 1, 2, and 3
Intravenous Dose Group 1 starting at 0.1 mg/kg and escalated in Dose Groups 2 (0.2 mg/kg) and Dose Group 3 (0.1, 0.2, 0.3, 0.4 mg/kg, titrated based on titration rules, administered every 14 days)
Biological: Sotatercept
Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
Other Name: ACE-011

Experimental: Subcutaneous Dose Group 1, 2, and 3
Subcutaneous Dose Group 1 starting at 0.13 mg/kg and escalated in Dose Groups 2 (0.26 mg/kg) and Dose Group 3 (0.4 to 0.5 mg/kg, titrated based on titration rules, administered every14 days)
Biological: Sotatercept
Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
Other Name: ACE-011




Primary Outcome Measures :
  1. Pharmacokinetics (Cmax) [ Time Frame: 28 days ]
    Maximum observed concentration in serum

  2. Pharmacokinetics (Tmax) [ Time Frame: 28 days ]
    Time to maximum concentration

  3. Pharmacokinetics (AUC 28d) [ Time Frame: 28 days ]
    Area under the concentration-time curve

  4. Pharmacokinetics (t1/2,z) [ Time Frame: 211 days ]
    Terminal half life

  5. Adverse Event [ Time Frame: 211 days ]
    treatment emergent adverse sevents (TEAEs) and number of subjects with TEAEs.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 113 days ]
    Change in mean hemoglobin concentration between baseline and day 113

  2. Bone Turnover [ Time Frame: 211 days ]
    Change in serum bone biomarker concentrations between baseline and end of study (day 211)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ≥ 18 years of age.
  2. Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening
  3. Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta [Mircera]) to maintain hemoglobin.
  4. A mean predialysis hemoglobin concentration ≥ 10 g/dL (grams per deciliter) to ≤ 12 g/dL (≥ 100 g/L (grams per liter) to ≤ 120 g/L) obtained from three consecutive days.

4. A Body Mass Index value ≥ 18.5 kg/m2 (kilograms per m2) at screening. 5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

6. Able to adhere to the study visit schedule and comply with all protocol requirements.

Exclusion Criteria:

  1. Non renal causes of anemia
  2. Subjects on peritoneal dialysis.
  3. Systemic hematological disease
  4. Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) > 9%) at screening.
  5. Uncontrolled hypertension defined as mean of home systolic blood pressure > 160 mm Hg (millimeter of mercury) or mean of home diastolic blood pressure > 90 mm Hg calculated once during the screening period prior to randomization
  6. Subjects with heart failure
  7. History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years ago).
  8. Anticipated or scheduled living donor renal transplant during the course of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999582


Locations
Show Show 23 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: William Smith, MD Celgene Corporation

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01999582    
Other Study ID Numbers: ACE-011-REN-002
2012-003788-23 ( EudraCT Number )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Keywords provided by Celgene:
Anemia
End Stage Kidney Disease
Chronic Kidney Disease
Dialysis
Erythrpoietin Stimulating Agent (ESA)
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic