Clinical Trials Logo
  1. Home
  2. Anemia
  3. NCT00148421
  4. Details
NCT00148421 Clinical Trial

Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Anemia Clinical Trial

Official title:
A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00148421
Other study ID # 20030125
Secondary ID
Status Completed
Phase Phase 3
First received June 30, 2005
Last updated May 13, 2013

Study information
Verified date May 2013
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Description:

The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Darbepoetin alfa and Epoetin alfa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (1)

20030125 Study Group Trial, Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Reduced incidence of transfusions
Secondary Change in hemoglobin concentration
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 NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation 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 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