Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212875
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-09-16
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 40000 Units given under the skin every six weeks can maintain hemoglobin within the range of 11-12 gdL in patients with anemia of CKD
Detailed Description:
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 gdL or Hb increases too rapidly eg 10 gdL 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 10000 U once every week 20000 U every two weeks 20000 U every 4 weeks or 40000 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 gdL 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 40000 U given SC every six weeks Q6W can maintain Hb within the range of 11-12 gdL 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 40000 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 gdL 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 10000 units U every week 20000 U every 2 weeks 20000 U every 4 weeks or 40000 U every 4 weeks for 16 weeks Protocol Addendum Patients will receive epoetin alfa 40000 U every 6 weeks over 12 weeks
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 gdL or Hb increases too rapidly eg 10 gdL 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 10000 U once every week 20000 U every two weeks 20000 U every 4 weeks or 40000 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 gdL 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 40000 U given SC every six weeks Q6W can maintain Hb within the range of 11-12 gdL 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 40000 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 gdL 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 10000 units U every week 20000 U every 2 weeks 20000 U every 4 weeks or 40000 U every 4 weeks for 16 weeks Protocol Addendum Patients will receive epoetin alfa 40000 U every 6 weeks over 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None