PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00440466
First received: February 26, 2007
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week


Condition Intervention Phase
Anemia
Renal Diseases
Drug: epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Extended Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, With the Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment [ Time Frame: from baseline (Week 1) to the last 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL) [ Time Frame: Weeks 13-37 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL) [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL) [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks) [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Died [ Time Frame: 36 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 430
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Drug: epoetin alfa
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Experimental: 003
epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Drug: epoetin alfa
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Experimental: 002
epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Drug: epoetin alfa
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Detailed Description:

A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
  • Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
  • History of increase in hemoglobin after the initial dose
  • Stable dose of epoetin alfa given once-weekly before randomization.

Exclusion Criteria:

  • Uncontrolled hypertension
  • Iron deficiency
  • iron overload
  • severe congestive heart failure
  • Active infection
  • Recent heart attack, Stroke or blood clot.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440466

  Show 66 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00440466     History of Changes
Other Study ID Numbers: CR010414, EPOAKD3002
Study First Received: February 26, 2007
Results First Received: May 13, 2010
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Reduction in the number of erythrocytes
Hemoglobin low level
Red blood cell deficiency
Procrit
Epoetin alfa
Chronic kidney disease

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014