Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Study ID
20110226

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact
Cassie Livingston
214/645-8296
cassie.livingston@utsouthwestern.edu

Principal Investigator
Ramesh Saxena, M.D., Ph.D.

Official Title

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Brief Overview


A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with
chronic kidney disease and not on dialysis will be randomized 1:1 to 1 of 2 dosing
strategies to evaluate the proportion of subjects receiving at least one red blood cell
transfusion. In the Hb-based titration group, darbepoetin alfa doses will be titrated to
maintain hemoglobin (Hb) ≥ 10.0 g/dL. In the fixed dose group, subjects will receive a fixed
dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb
concentrations will be blinded. Subjects will be followed for approximately 2 years from the
date of randomization.

Summary


The study is a phase 3, multicenter, randomized, double-blind, parallel group study designed
to describe the benefits and potential risks of a new treatment strategy using a fixed dose
of darbepoetin alfa in subjects with chronic kidney disease and not on dialysis. Anemic
subjects without recent use of an erythropoiesis stimulating agent (ESA) will be randomly
allocated 1:1 to treatment with a fixed dose of darbepoetin alfa or to treatment with
darbepoetin alfa using a hemoglobin (Hb)-based titration strategy, which has been the
conventional dosing strategy. In the Hb-based titration group, darbepoetin alfa doses will
be titrated to maintain hemoglobin (Hb) ≥ 10.0 g/dL. This study aims to estimate the
incidence of red blood cell (RBC) transfusions (administered as deemed clinically necessary)
in each group and the difference in incidence of RBC transfusions between the 2 groups. In
addition, multiple aspects, such as cumulative darbepoetin alfa dose, total number of units
of transfusions, Hb concentration, Hb-related parameters (eg, Hb variability, excursions,
rate of change), and adverse (eg, cardiovascular) events, will also be considered in order
to determine a preferred dosing regimen. Treatment group, darbepoetin alfa doses, and
protocol specified Hb concentrations will be blinded to the investigator, subjects and study
team. Subjects will be followed for approximately 2 years from the date of randomization.

Participant Eligibility


Key Inclusion Criteria:

- Hb concentration < 10.0 g/dL

- Estimated glomerular filtration rate of < 45.0 mL/min/1.73m2

- Transferrin saturation (TSAT) ≥ 20% and ferritin ≥ 100 ng/mL

- Clinically stable by the investigator

Key Exclusion Criteria:

- Received erythropoiesis stimulating agents (ESAs) within 4 weeks of screening

- Received a red blood cell transfusion within 8 weeks of screening

- Received intravenous iron or had changes to oral iron therapy within 4 weeks of
screening

- Uncontrolled hypertension, defined in this study, as a mean systolic blood pressure >
140 mmHg at both screening visits, or a mean systolic blood pressure >/= 160 mmHg at
any screening visit, or a mean diastolic blood pressure >/= 90 mmHg at any screening
visit.