Overview

This trial is active, not recruiting.

Condition management of anemia in chronic kidney disease patients not on dialysis
Treatment darbepoetin alfa
Phase phase 3
Sponsor Amgen
Start date July 2012
End date October 2017
Trial size 756 participants
Trial identifier NCT01652872, 20110226

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Subjects randomized to the hemoglobin based titration group will have their dose of investigational product titrated based on the hemoglobin concentration on the date of the visit, the corresponding hemoglobin rate of rise, and the previously assigned dose.
darbepoetin alfa
Darbepoetin alfa will be presented as single use prefilled syringes. Investigational product will be administered subcutaneously every 4 weeks for the duration of the treatment period.
(Active Comparator)
Subjects randomized to the fixed dose group will receive the same dose as the one assigned at the time of randomization for the duration of the treatment period with one exception: if the hemoglobin is > 12.0 g/dL, darbepoetin alfa therapy will be withheld until the hemoglobin falls below 10.0 g/dL.
darbepoetin alfa
Darbepoetin alfa will be presented as single use prefilled syringes. Investigational product will be administered subcutaneously every 4 weeks for the duration of the treatment period.

Primary Outcomes

Measure
Receipt of 1 or more RBC transfusion
time frame: Approximately 2 years

Secondary Outcomes

Measure
Total number of units of red blood cells (RBC) transfused. Time to first red blood cell transfusion.
time frame: Approximately 2 years
Average achieved hemoglobin (Hb) concentration while receiving investigational product.
time frame: Up to 2 years
Cumulative dose of darbepoetin alfa
time frame: Up to 2 years
Time to first RBC transfusion
time frame: From randomization to the first RBC transfusion

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Amgen.