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Anemia | Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Anemia research study

What is the primary objective of this study?

The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

Who is eligible to participate?

Inclusion Criteria: - Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis - Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL - Transferrin saturation (Tsat) greater than or equal to 20% Exclusion Criteria: - Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization - other hematologic disorders - upper or lower gastrointenstinal bleeding within 6 months prior to randomization - uncontrolled hypertension - prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack - prior history (within 6 months prior to randomization) of thromboembolism

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anemia

Chronic Kidney Disease

Kidney Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Darbepoetin AlfaAdministered by subcutaneous or intravenous injection

Drug:PlaceboMatching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Darbepoetin Alfa QWParticipants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Darbepoetin Alfa Q2WParticipants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Study Status

Terminated

Start Date: September 16, 2008

Completed Date: March 3, 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL

Secondary Outcome: Time to First Hemoglobin Value ≥ 10.0 g/dL

Study sponsors, principal investigator, and references

Principal Investigator: MD

Lead Sponsor: Amgen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00436748

Warady BA, Barcia J, Benador N, Jankauskiene A, Olson K, Podracka L, Shavkin A, Srivaths P, Wong CJ, Petersen J. De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2018 Jan;33(1):125-137. doi: 10.1007/s00467-017-3758-5. Epub 2017 Aug 17.

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