Clinical Trials Logo
  1. Home
  2. Anemia
  3. NCT00117247
  4. Details
NCT00117247 Clinical Trial

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

Anemia Clinical Trial

Official title:
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Repeat-Sose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00117247
Other study ID # 20010198
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 30, 2005
Last updated October 15, 2009
Start date June 2002
Est. completion date July 2004

Study information
Verified date October 2009
Source Amgen
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• darbepoetin alfa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic profiling of Aranesp® in HF pts
Secondary Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1

External Links