A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00337935
First received: June 16, 2006
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.


Condition Intervention Phase
Renal Failure , Chronic
Anemia
Drug: Epoetin Alfa
Other: Standard of care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Patients Achieved a Hemoglobin Response. [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL

  • Time to Hemoglobin Response [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.


Enrollment: 157
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin Alfa Drug: Epoetin Alfa
Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Group 2
Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).
Other: Standard of care
Other Name: Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).

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  Eligibility

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

Inclusion Criteria:

  • Chronic Kidney Disease (CKD) Stage 3, 4, or 5 (not on dialysis), Glomerular Filtration Rate (GFR) [<60 mL/min/1.73 m2], or CKD Stage 2 (GFR 61-90 mL/min/1.73 mm2) with evidence of kidney damage (defined as structural or functional abnormalities of the kidneys) for greater than 3 months
  • Hb <11 g/dL measured at screening and a stable creatinine over the last 3 months
  • expected to stay in a Long Term Care (LTC) facility for at least six months
  • not receiving erythropoietic agents within eight weeks prior to screening.

Exclusion Criteria:

  • No significant hematological disease (including, but not limited to, myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy), or with a current diagnosis of anemia due to blood loss (e.g., hemolysis or gastrointestinal bleeding) or any cause of anemia other than CKD (e.g., hypothyroidism, HIV)
  • No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months prior to screening (prior superficial thrombophlebitis is not an exclusion criterion), or a history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS), or other arterial thrombosis within 6 months before study entry. [ACS includes Unstable Angina, Q wave Myocardial Infarction and non-Q wave Myocardial Infarction]
  • No uncontrolled or severe cardiovascular disease including uncontrolled hypertension (systolic BP > 170 mm/Hg, or diastolic BP > 100 mm/Hg), or congestive heart failure (New York Heart Association (NYHA) Class IV)
  • No known solid tumor malignancy, receiving chemotherapy for cancer or having major surgery within one month prior to screening or expected during study participation
  • No history of receiving a transplanted organ, or scheduled to receive an organ transplant during the course of the study, with the exception of a corneal transplant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337935

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Clinical Affairs, 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

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00337935     History of Changes
Other Study ID Numbers: CR012229
Study First Received: June 16, 2006
Results First Received: July 16, 2010
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Long Term Care Facilities
subcutaneous injections
PROCRIT
Epoetin alfa
Anemia

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

ClinicalTrials.gov processed this record on April 16, 2014