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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
AnemiaKidney 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.

Trial Locations (23)

3000

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg, Leuven

4000

CHR de la CITADELLE, Liège

7331

Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour, Baudour

8000

Nephrocare Faro, Faro

14004

Hospital Universitario Reina Sofia, Córdoba

28007

Servicio de Nefrologia Hospital General Universitario Gregorio Maranon, Madrid

28041

Hospital 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid

39008

Hospital Universitario Marques de Valdecilla, Santander, Cantabria

40210

Gemeinschaftspraxis und Dialysezentrum Karlstrass, Düsseldorf

48960

Hospital Galdakao-Usansolo, Galdakao

80337

KfH Kuratorium für Dialyse und Nierentransplantation e.v., München

83022

KfH Nierenzentrum Rosenheim, Rosenheim

96450

KfH Nierenzentrum Coburg, Coburg

1649-035

Hospital de Santa Maria, Lisbon

8500-311

Nephrocare Portimao, Portimão

04009

Complejo Hospitalario de Torrecardenas, Almería

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic of Barcelona, Barcelona

03186

Hospital de Torrevieja, Torrevieja (Alicante)

CB2 0QQ

Cambridge University Hospitals NHS Trust, Cambridge

G11 6NT

Glasgow Royal Infirmary, Glasgow

SW17 0QT

St Georges Healthcare NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01999582 - A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis | Biotech Hunter | Biotech Hunter