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

NCT ID: NCT01999582

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Anemia; Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Sotatercept

Intervention Type: BIOLOGICAL

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

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)

Group Type: EXPERIMENTAL

Sotatercept

Intervention Type: BIOLOGICAL

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

Interventions

Sotatercept

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

Intervention Type: BIOLOGICAL

Sotatercept

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

Intervention Type: BIOLOGICAL

Other Intervention Names

ACE-011; ACE-011

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Smith, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour

Baudour, , Belgium

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

Leuven, , Belgium

CHR de la CITADELLE

Liège, , Belgium

KfH Nierenzentrum Coburg

Coburg, , Germany

Gemeinschaftspraxis und Dialysezentrum Karlstrass

Düsseldorf, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.v.

München, , Germany

KfH Nierenzentrum Rosenheim

Rosenheim, , Germany

Nephrocare Faro

Faro, , Portugal

Hospital de Santa Maria

Lisbon, , Portugal

Nephrocare Portimao

Portimão, , Portugal

Complejo Hospitalario de Torrecardenas

Almería, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinic of Barcelona

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Galdakao-Usansolo

Galdakao, , Spain

Servicio de Nefrologia Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, , Spain

Hospital de Torrevieja

Torrevieja (Alicante), , Spain

Cambridge University Hospitals NHS Trust

Cambridge, , United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

St Georges Healthcare NHS Trust

London, , United Kingdom

Countries

Belgium; Germany; Portugal; Spain; United Kingdom

Other Identifiers

2012-003788-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACE-011-REN-002

Identifier Type: -

Identifier Source: org_study_id