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:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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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).
|
Show Detailed Description 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 June 18, 2013