Sotatercept Safety and Effects on Hemoglobin, Bone, and Vascular Calcification.

ABSTRACT:

Introduction

Patients with end-stage kidney disease (ESKD) exhibit anemia, chronic kidney disease‒mineral bone disorder (CKD-MBD), and cardiovascular disease. The REN-001 and REN-002 phase II, multicenter, randomized studies examined safety, tolerability, and effects of sotatercept, an ActRIIA-IgG1 fusion protein trap, on hemoglobin concentration; REN-001 also explored effects on bone mineral density (BMD) and abdominal aortic vascular calcification.

Methods

Forty-three patients were treated in REN-001 (dose range: sotatercept 0.3‒0.7 mg/kg or placebo subcutaneously [s.c.] for 200 days) and 50 in REN-002 (dose range: 0.1‒0.4 mg/kg i.v. and 0.13‒0.5 mg/kg s.c. for 99 days).

Results

In REN-001, frequency of achieving target hemoglobin response (>10 g/dl [6.21 mmol/l]) w

SUBMITTER: Coyne DW 

PROVIDER: S-EPMC6933454 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature