MedDataX Logo

A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

NCT ID: NCT00117247

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

NCT00086086

Congestive Heart Failure Anemia
COMPLETED PHASE2

Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

NCT00119587

Anemia
COMPLETED PHASE3

Phase 2 Study of Darbepoetin Alfa Extended Dosing

NCT00527215

Pre-Dialysis
COMPLETED PHASE2

Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

NCT00096915

Kidney Disease Chronic Kidney Disease
COMPLETED PHASE3

Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

NCT00436995

Chronic Kidney Disease
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Congestive Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

darbepoetin alfa

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: - Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme \[ACE\] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amgen Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20010198

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
NCT00093977 COMPLETED PHASE3
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
NCT00925587 COMPLETED PHASE3
Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease
NCT00121602 COMPLETED PHASE3
Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
NCT00111098 COMPLETED PHASE3
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
NCT00436748 TERMINATED PHASE3
Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study
NCT07025460 ACTIVE_NOT_RECRUITING PHASE4
STAAR-1 Clinical Study
NCT00369772 COMPLETED PHASE4
CKD-11101 Phase 3 SC Study
NCT03431623 COMPLETED PHASE3
An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
NCT00124098 COMPLETED PHASE3
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
NCT00213291 COMPLETED PHASE3
A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
NCT00907608 TERMINATED NA
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
NCT00559273 COMPLETED PHASE3
Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
NCT00563446 COMPLETED NA
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
NCT00359840 COMPLETED PHASE2
Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis
NCT00112008 COMPLETED PHASE3
Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
NCT05691257 UNKNOWN PHASE4
Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
NCT00093015 COMPLETED PHASE3
Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
NCT01652872 COMPLETED PHASE3
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
NCT00495365 TERMINATED PHASE4
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
NCT00605345 COMPLETED PHASE3
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
NCT00560547 WITHDRAWN PHASE3
Absorption and Elimination of Radiolabeled Daprodustat
NCT03239522 COMPLETED PHASE1
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
NCT00261521 COMPLETED PHASE3
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
NCT00364845 TERMINATED PHASE3
Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
NCT00314795 COMPLETED PHASE2