A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease

NCT00641589 | Completed Phase 1

• 1 other identifier: CR002299
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD).

Conditions

Chronic Kidney Disease; Anemia

Keywords

Chronic Kidney Disease; anemia; epoetin alfa

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.

Secondary Outcomes (1)

• The secondary objective is to describe the pharmacodynamic (PD) response to the four PROCRIT study dosing regimens using the following outcomes: absolute and % reticulocyte count, hemoglobin (Hb), hematocrit (Hct), and red blood cell (RBC) count.

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a Glomerular Filtration Rate (GFR) within 15-60 mL/min/1.73m2 and stable creatinine over the past 6 months and no expected need for dialysis during the study
• Patients with a hemoglobin (Hg) \< 11 g/dL at Screening
• Patients with a transferrin saturation \>= 20% or a ferritin \>= 50 ng/mL.
• Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose
• Patients with reproductive potential must have a negative B-HCG pregnancy test within 14 days of the first dose of study drug and a negative urine pregnancy test on the day of the first dose of study drug
• Patients and their partners must be practicing an effective method of birth control before entry and throughout the study

You may not qualify if:

• including but not limited to myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy)
• Patients with liver function test results \> 2 or more times the normal value
• Patients with new onset seizures (within the last 3 months) or seizures not controlled by medication prior to admission in to the study
• Patients with a history of thrombotic vascular events (including by not limited to acute myocardial infarction (AMI) within the previous 6 months, stroke, transient ischemic attack (TIA), deep vein thrombosis,(DT) and pulmonary embolism (PE)
• Patients with poorly controlled or uncontrolled hypertension
• Patients with anemia due to blood loss.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Centocor Ortho Biotech Services, L.L.C.: collaborator

Related Links

• An open-label, randomized study to deteremine the pharmacokinetic and pharmacodynamic profiles of PROCRIT (Epoetin alfa) in anemic subjects with chronic kidney disease

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 18, 2011

Record last verified: 2010-04