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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00337935 |
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Date of registration:
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16/06/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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 |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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157 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00337935 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Failure , Chronic
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Anemia
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Intervention(s)
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Drug: Epoetin Alfa
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Other: Standard of care
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Primary Outcome(s)
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Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)
[Time Frame: Week 0 to Week 26]
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Secondary Outcome(s)
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The Number of Patients Achieved a Hemoglobin Response.
[Time Frame: Week 0 to Week 26]
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Time to Hemoglobin Response
[Time Frame: Week 0 to Week 26]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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