Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
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ClinicalTrials.gov Identifier: NCT00210743 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: May 23, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia Kidney Diseases | Drug: epoetin alfa | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week Epoetin Alfa (PROCRIT)in the Treatment of Subjects With the Anemia of Chronic Kidney Disease (CKD) |
Study Start Date : | May 2004 |
Actual Study Completion Date : | October 2005 |

- The primary endpoint is the number of subjects who achieve a hemoglobin response after receiving PROCRIT every 2 weeks. Hemoglobin response is defined as achieving a target hemoglobin range of 11-12 g/dL for at least 2 consecutive weeks by Week 28.
- The secondary endpoints include: the time to a hemoglobin response, the number of subjects achieving a 1 g/dL rise in hemoglobin, change in quality of life measurements, and the total study drug dose up to the time of response.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study
- subjects with a hemoglobin less than 11 g/dL
- subjects who have not received erythropoietic agents within 6 weeks before study entry
- female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug.
Exclusion Criteria:
- Subjects with poorly controlled high blood pressure (hypertension) - systolic > 150 mm Hg or diastolic > 100 mm Hg
- known hypersensitivity to human albumin and/or mammalian cell-derived products
- subjects receiving dialysis
- subjects with a ferritin level < 50 ng/mL, Transferrin Saturation < 20%
- subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation
- Pregnancy or lactation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210743
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00210743 History of Changes |
Other Study ID Numbers: |
CR004600 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | May 23, 2011 |
Last Verified: | April 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia chronic kidney disease erythropoetin, Epoetin alfa erythropoetin recombinant pre-dialysis |
Additional relevant MeSH terms:
Anemia Kidney Diseases Renal Insufficiency, Chronic Hematologic Diseases |
Urologic Diseases Renal Insufficiency Epoetin Alfa Hematinics |