Clinical Trials Logo
  1. Home
  2. Kidney Diseases
  3. NCT00117130
  4. Details
NCT00117130 Clinical Trial

Study to Evaluate Effectiveness of Aranesp®

Kidney Disease Clinical Trial

Official title:
Aranesp® Monthly Preference Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00117130
Other study ID # 20020147
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2005
Last updated January 20, 2011

Study information
Verified date January 2011
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

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: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aranesp®

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary Subject preference
Secondary Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.
See also
  Status Clinical Trial Phase
Completed NCT02369354 - Transplant Social Worker Support for Live Kidney Donation in African Americans N/A
Not yet recruiting NCT02225782 - Trial to Compare 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring Hemodialysis Catheter Function Phase 4
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Withdrawn NCT00585429 - Evaluation of Kidney Disease in Liver Transplant Recipients N/A
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00183248 - Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients Phase 1/Phase 2
Completed NCT00001835 - Oxaliplatin in Cancer Patients With Impaired Kidney Function Phase 1
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Terminated NCT00436748 - Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease Phase 3
Completed NCT01467466 - Prevention of Serious Adverse Events Following Angiography Phase 3
Completed NCT01235936 - Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia Phase 2
Completed NCT01947829 - Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY) N/A
Completed NCT01974999 - A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
Recruiting NCT01240564 - The Nephrotic Syndrome Study Network (NEPTUNE) N/A
Active, not recruiting NCT01228903 - Uric Acid and the Endothelium is CKD N/A
Completed NCT00734357 - Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients N/A
Completed NCT00781417 - Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease N/A
Completed NCT00096915 - Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis Phase 3
Completed NCT00094484 - Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis Phase 3
Completed NCT00093977 - Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease Phase 3

External Links