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.
|First Submitted Date ICMJE||September 16, 2005|
|First Posted Date ICMJE||September 21, 2005|
|Last Update Posted Date||May 23, 2011|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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)|
|Original Primary Outcome Measures ICMJE
||To explore hemoglobin response, defined as achieving a hemoglobin increase of greater than 1.0 g/dL from baseline anytime during the study.|
|Change History||Complete list of historical versions of study NCT00212875 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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.|
|Original Secondary Outcome Measures ICMJE
||Time to Hb response; patients with Hb > 11g/dL and an increase =>1g/dL from baseline during study; Final Hb change from baseline; Change in Hb over time; Treatment failures; Blood transfused; PROCRIT dose when Hb response is achieved and at end of study|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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.|
|Official Title ICMJE||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). Protocol Addendum: Due to Space Constraints, See Detailed Description for Full Title of Addendum.|
|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.|
Patients with chronic kidney disease (CKD) develop anemia due to reduced erythropoietin production by the kidney. Correction of anemia has been shown to improve exercise capacity, cognition, quality of life and may slow disease progression.
The primary objective of this study is to compare the change in hemoglobin (Hb) that occurs from study start to the end of the study in pre-dialysis patients with anemia of chronic kidney disease (CKD) who are receiving PROCRIT (epoetin alfa) once every two weeks (Q2W) and once every four weeks (Q4W). This study will enroll 259 patients who will be randomly assigned (assigned to a treatment group by chance) to receive epoetin alfa subcutaneously (SC, under the skin) at one of four doses.
This study will have a Screening Phase of up to one week when patients will be evaluated for study eligibility followed by an open-label Treatment Phase of 16 weeks when patients will be randomly assigned to receive epoetin alfa administered under the skin at one of four dosing regimens. Patients will then complete a Post-Treatment Follow-Up Phase of 1 week (Week 17). Hemoglobin will be measured weekly. There will be no dose adjustments during the initial 4 weeks of the study, however, the dose may be withheld during this time if necessary. Further dose increases may occur at 4-week intervals and dose reductions may occur as frequently as the dosing interval assigned at randomization.
Patients will be eligible for epoetin alfa dose adjustments starting at the Week 5 visit if Hb is > 12 g/dL or Hb increases too rapidly (e.g., >1.0 g/dL in the last one or two consecutive weeks). The last dose of epoetin alfa administered for any treatment group will coincide with the dosing frequency assigned to that group. Epoetin alfa will not be administered later than Week 16 for any treatment group.
Hematology, serum chemistry, and iron status will be assessed at intervals throughout the study. The number of units of blood transfused, pre-transfusion Hb level, and the reasons for transfusion will be collected. Clinical laboratory results, vital signs, and the incidence and severity of adverse events will be assessed and monitored during the study.
Protocol Addendum: An Open-Label Extension of PROCRIT (Epoetin alfa) Maintenance Therapy Administered Every Six Weeks (Q6W) for the Treatment of Anemia of Chronic Kidney Disease (CKD). The Main Protocol, as described above, was designed to evaluate whether patients with anemia of CKD could be started on epoetin alfa therapy at one of four dosing regimens: 10,000 U once every week, 20,000 U every two weeks, 20,000 U every 4 weeks, or 40,000 U every four weeks. As an addendum to the Main Protocol, up to sixty (60) patients completing the original protocol with a hemoglobin (Hb) between 11 and 12 g/dL will be given an opportunity to enroll in an open-label extension study that will begin at the end of the Main Protocol timeline (Week 17). The primary objective of this open-label extension is to evaluate if epoetin alfa 40,000 U given SC every six weeks (Q6W), can maintain Hb within the range of 11-12 g/dL in patients with anemia of chronic kidney disease (CKD).
This open-label extension will have a Screening Phase of up to one week (during Week 17) when patients will be evaluated for eligibility, an Open-Label Treatment Phase of 12 weeks duration (Weeks 18-Week 30), and a Post-Treatment Follow-Up Phase of 6 weeks (ending at Week 36 or 6 weeks from the date of the last dose of epoetin alfa). All patients will receive a first dose of epoetin alfa 40,000 U SC every 6 weeks beginning with Week 18, a second dose at Week 24, and a third and final dose at Week 30. During the Treatment Phase, Hb will be measured weekly. Dosing will not be increased during the open-label extension. A six-week follow-up period is required after administration of the Week 30 dose for those patients receiving all 3 doses. If Hb falls below 10 g/dL at any time or if the patient requires a red blood cell (RBC) transfusion, the patient will be withdrawn from the open-label extension, and the Post-Treatment Follow-Up Phase will occur 6 weeks later.
Hematology, serum chemistry, and iron status will be assessed at intervals throughout the study. The number of units of blood transfused, pre-transfusion Hb level, and the reasons for transfusion will be collected. Clinical laboratory results, vital signs, and the incidence and severity of adverse events will be assessed and monitored during the study. Patients will receive epoetin alfa under the skin (SC) at a dose of 10,000 units (U) every week, 20,000 U every 2 weeks, 20,000 U every 4 weeks or 40,000 U every 4 weeks for 16 weeks. Protocol Addendum: Patients will receive epoetin alfa 40,000 U every 6 weeks over 12 weeks.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Drug: epoetin alfa|
|Study Arms||Not Provided|
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Protocol Addendum: Patients must have participated in the Main Protocol of this study and completed all study-related procedures
Protocol Addendum: No patients with a transferrin saturation (TSAT) <20% and a ferritin <50 ng/mL
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00212875|
|Other Study ID Numbers ICMJE||CR003397|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Collaborators ICMJE||Centocor Ortho Biotech Services, L.L.C.|
|PRS Account||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Verification Date||March 2010|
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