A Study of Four Dosing Regimens of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease. Protocol Addendum: Extension Study of Maintenance Therapy of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease.

NCT00212875 | Completed Phase 2

• 1 other identifier: CR003397
• Study Type: interventional
• Target: 267
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to compare the change in hemoglobin (Hb) from study start to the end of the study between the every 2 week and the every 4 week dosing regimens in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa). Protocol Addendum: The primary objective of the open-label extension portion of this study is to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.

Conditions

Chronic Kidney Disease; Anemia

Keywords

Chronic Kidney disease; anemia

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)

Secondary Outcomes (1)

• Hb response (defined as achieving a Hb increase =>1g/dL from baseline any time during study); Change in Hb over time; Treatment failures; Blood transfused; Epoetin alfa dose when Hb is achieved and at study end.

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have CKD with Hg level \<11 g/dL at study start
• must not have received any erythropoietic agents within 8 weeks of study start
• Patients with reproductive potential and their partners must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study, female subjects with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of epoetin alfa
• Patients must have signed informed consent documents indicating that they agree to participate in the study, including the completion of all study-related procedures and evaluations.
• Protocol Addendum: Patients must have participated in the Main Protocol of this study and completed all study-related procedures
• Patients must have a Hb between 11-12 g/dL at baseline (measured by HemoCue)
• Patients must have CKD defined as glomerular filtration rate (GFR) \>=15 to \<=90 mL/min as determined using the Modification of Diet for Renal Disease (MDRD) equation.

You may not qualify if:

• No patients receiving dialysis or scheduled to receive dialysis during the course of the study
• No patients with a current diagnosis of poorly controlled hypertension after adequate antihypertensive therapy or those with severe congestive heart failure (New York Heart Association Class IV), or known severe stable or unstable coronary artery disease
• No patients receiving chemotherapy for cancer within 3 months prior to study start or expected during study participation
• No patients with a current diagnosis of anemia due to Vitamin B12 deficiencies, hemolysis, or gastrointestinal bleeding or a history of/or active blood or bleeding disorders (this includes but is not limited to porphyria, thalassemia, myelodysplastic syndrome, and sickle cell anemia. No patients with liver diseases or any other diseases known to cause anemia
• No patients with a past history of thrombotic vascular events, (including but not limited to stroke, transient ischemic attack, myocardial infarction, coronary artery disease, and deep venous thrombosis) within the past 5 years
• No patients with a life expectancy of \<= 6 months
• No women who are currently pregnant or lactating. No patients previously unresponsive to erythropoietic agents.
• Protocol Addendum: No patients with a transferrin saturation (TSAT) \<20% and a ferritin \<50 ng/mL
• No patients with an epoetin alfa dose reduction/hold within the past four weeks of treatment in the Main Protocol, for a Hb rate of rise (\>1 g/dL over 1 or 2 consecutive weeks),or a Hb above 12 g/dL
• No patients with iron overload defined as a TSAT \> 70% or a ferritin \> 1000 ng/mL
• No patients with a serum albumin concentration \< 2.6 g/dL, or unstable angina
• No patients with chemotherapy for cancer within 3 months prior to baseline or expected during open-label extension participation
• No patients with known solid tumor malignancy or with new onset seizures within 3 months or seizures not controlled by medication prior to baseline. No patients receiving transfusion of platelets or packed red blood cells within 28 days prior to the first dose of epoetin alfa. No patients who have been previously unresponsive to erythropoietic agents, including patients who were treatment failures during the Main Protocol.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Centocor Ortho Biotech Services, L.L.C.: collaborator

Related Publications (1)

• Spinowitz B, Germain M, Benz R, Wolfson M, McGowan T, Tang KL, Kamin M; Epoetin Alfa Extended Dosing Study Group. A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2008 Jul;3(4):1015-21. doi: 10.2215/CJN.05681207. Epub 2008 Apr 9.

  PMID: 18400964 DERIVED

Related Links

• An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT (Epoetin alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD)
• An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT (Epoetin alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD)

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2005
• Study Completion: February 1, 2007
• Last Updated: May 23, 2011

Record last verified: 2010-03