Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337935
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2006-06-16
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PROCRIT Epoetin alfa is a brand of recombinant human erythropoietin rHuEPO Erythropoietin is a hormone produced in the kidney Its function is to stimulate the production of red blood cells in the bone marrow Many patients with Chronic Kidney Disease CKD do not produce enough erythropoietin and thus develop anemia a reduction in red blood cell levels This can cause them to feel tired
PROCRIT Epoetin alfa is approved by the United States Food and Drug Administration FDA for the treatment of anemia low red blood cell count in patients with CKD not on dialysis The approved dosing frequency for PROCRIT Epoetin alfa in patients with CKD is one injection three times per week Although PROCRIT Epoetin alfa is approved by the FDA for the treatment of certain types of anemia at different dosing schedules the dosing schedules that will be used in this study are investigational in CKD An investigational use is one that is currently not approved by the FDA
This is an open-label randomized patients are assigned different treatments based on chance multi-center controlled study of patients with anemia of Chronic Kidney Disease CKD not on dialysis who reside in long-term care facilities Approximately 156 patients with CKD not on dialysis who have not received an erythropoietin receptor agonist a drug that stimulates red blood cell production for eight weeks immediately prior to screening Week -1 and who have a hemoglobin Hb a measure of the number of red blood cells less than 11 gdL at screening will be eligible to participate Patients will be evaluated for eligibility during a one-week screening phase Eligible patients will be randomized in a 31 ratio to a PROCRIT Epoetin alfa group or to the control group for a period of 26 weeks Randomization is done through a computer that randomly assigns the subject by chance like rolling dice to one of two groups No one can choose the group to which they will be assigned They will have a 3 to 1 chance of being assigned to Group 1 versus Group 2 which means that out of every 4 patients entering the study 3 will receive PROCRIT Epoetin alfa and 1 will not
Group 1 -will receive PROCRIT Epoetin alfa 20000 Units U every 2 weeks until the hemoglobin reaches 110 gdL or higher and remains at this level for two measurements in a row At Week 6 or thereafter the 20000 Unit dose may be adjusted upward or downward as required to obtain the two consecutive hemoglobin measurements Once the two consecutive measurements have been achieved PROCRIT Epoetin alfa will be given every 4 weeks Q4W at double the previous dose to obtain a target hemoglobin of up to 120 gdL There will be no conversion to Q4W before Week 6 or after Week 18 If the hemoglobin drops patients may go back to receiving PROCRIT Epoetin alfa every 2-weeks If the hemoglobin rises above 120 gdL patients will not receive another dose of PROCRIT Epoetin alfa until the Hg level is below 120 gdL If the hemoglobin rises rapidly patients will not receive another dose of PROCRIT Epoetin alfa until the rise is 1 gdL or less in a 2-week period The maximum amount of PROCRIT Epoetin alfa that this group can receive is 60000 Units over a 4-week period All doses of PROCRIT Epoetin alfa are injected under the skin subcutaneous
Group 2 - will not receive any PROCRIT Epoetin alfa This group will continue to receive the care that they are now receiving from their physician and the physician will review all lab results
Since a lack of iron could interfere with the ability of patients to make red blood cells patients in both groups will have iron levels checked at the screening visit and during the study Based on the results of iron tests the study doctor may prescribe an oral by mouth or intravenous injection iron supplement during the study If the need for iron supplementation is determined patients will receive iron supplementation no matter which group they are in
Every two weeks a study visit will be performed At each visit blood pressure and heart rate will be checked and blood will be drawn for all patients and sent to the central laboratory for complete blood count CBC The Hb by CBC will be used for efficacy analysis to measure the effectiveness of the study drug in increasing the hemoglobin level Hb testing by HemoCue will be performed every two weeks on-site for PROCRIT Epoetin alfa group patients for the purpose of real-time dosing decisions HemoCue is the brand name of a portable hemoglobin test that uses a drop of blood to obtain immediate hemoglobin measurements PROCRIT Epoetin alfa will be administered at a dose based on the HemoCue Hb measurement Full hematology panel serum chemistry and iron status will be assessed at intervals throughout the study by a central laboratory The number of units of packed red blood cells PRBC transfused pre-transfusion Hb level and the reasons for transfusion will be collected Hemoglobin response will also be measured A patient exhibiting a hemoglobin response will have two consecutive Hb measurements at least 1 gdL greater than baseline any time during the study or have two consecutive Hb measurements 110 gdL at any time during the study Falls activities of daily living ADLs and mobility will be assessed during the study Clinical laboratory results blood pressure and heart rate and the incidence and severity of adverse events will be monitored during the study
The study hypothesis is that the mean Hb change from baseline to the end of study will be significantly higher in the PROCRIT Epoetin alfa group over the control group Group 1 patients will receive a maximum of 13 doses of PROCRIT Epoetin alfa by subcutaneous injection under the skin for up to 26 weeks Dosage is based on the hemoglobin measurement done at each visit Doses will be started at an every 2-week interval and may be increased to every four weeks The maximum dose that can be given is 60000 Units of PROCRIT Epoetin alfa over a 4-week period Any PROCRIT Epoetin alfa dose over 40000 Units will be administered in two separate injections
PROCRIT Epoetin alfa is approved by the United States Food and Drug Administration FDA for the treatment of anemia low red blood cell count in patients with CKD not on dialysis The approved dosing frequency for PROCRIT Epoetin alfa in patients with CKD is one injection three times per week Although PROCRIT Epoetin alfa is approved by the FDA for the treatment of certain types of anemia at different dosing schedules the dosing schedules that will be used in this study are investigational in CKD An investigational use is one that is currently not approved by the FDA
This is an open-label randomized patients are assigned different treatments based on chance multi-center controlled study of patients with anemia of Chronic Kidney Disease CKD not on dialysis who reside in long-term care facilities Approximately 156 patients with CKD not on dialysis who have not received an erythropoietin receptor agonist a drug that stimulates red blood cell production for eight weeks immediately prior to screening Week -1 and who have a hemoglobin Hb a measure of the number of red blood cells less than 11 gdL at screening will be eligible to participate Patients will be evaluated for eligibility during a one-week screening phase Eligible patients will be randomized in a 31 ratio to a PROCRIT Epoetin alfa group or to the control group for a period of 26 weeks Randomization is done through a computer that randomly assigns the subject by chance like rolling dice to one of two groups No one can choose the group to which they will be assigned They will have a 3 to 1 chance of being assigned to Group 1 versus Group 2 which means that out of every 4 patients entering the study 3 will receive PROCRIT Epoetin alfa and 1 will not
Group 1 -will receive PROCRIT Epoetin alfa 20000 Units U every 2 weeks until the hemoglobin reaches 110 gdL or higher and remains at this level for two measurements in a row At Week 6 or thereafter the 20000 Unit dose may be adjusted upward or downward as required to obtain the two consecutive hemoglobin measurements Once the two consecutive measurements have been achieved PROCRIT Epoetin alfa will be given every 4 weeks Q4W at double the previous dose to obtain a target hemoglobin of up to 120 gdL There will be no conversion to Q4W before Week 6 or after Week 18 If the hemoglobin drops patients may go back to receiving PROCRIT Epoetin alfa every 2-weeks If the hemoglobin rises above 120 gdL patients will not receive another dose of PROCRIT Epoetin alfa until the Hg level is below 120 gdL If the hemoglobin rises rapidly patients will not receive another dose of PROCRIT Epoetin alfa until the rise is 1 gdL or less in a 2-week period The maximum amount of PROCRIT Epoetin alfa that this group can receive is 60000 Units over a 4-week period All doses of PROCRIT Epoetin alfa are injected under the skin subcutaneous
Group 2 - will not receive any PROCRIT Epoetin alfa This group will continue to receive the care that they are now receiving from their physician and the physician will review all lab results
Since a lack of iron could interfere with the ability of patients to make red blood cells patients in both groups will have iron levels checked at the screening visit and during the study Based on the results of iron tests the study doctor may prescribe an oral by mouth or intravenous injection iron supplement during the study If the need for iron supplementation is determined patients will receive iron supplementation no matter which group they are in
Every two weeks a study visit will be performed At each visit blood pressure and heart rate will be checked and blood will be drawn for all patients and sent to the central laboratory for complete blood count CBC The Hb by CBC will be used for efficacy analysis to measure the effectiveness of the study drug in increasing the hemoglobin level Hb testing by HemoCue will be performed every two weeks on-site for PROCRIT Epoetin alfa group patients for the purpose of real-time dosing decisions HemoCue is the brand name of a portable hemoglobin test that uses a drop of blood to obtain immediate hemoglobin measurements PROCRIT Epoetin alfa will be administered at a dose based on the HemoCue Hb measurement Full hematology panel serum chemistry and iron status will be assessed at intervals throughout the study by a central laboratory The number of units of packed red blood cells PRBC transfused pre-transfusion Hb level and the reasons for transfusion will be collected Hemoglobin response will also be measured A patient exhibiting a hemoglobin response will have two consecutive Hb measurements at least 1 gdL greater than baseline any time during the study or have two consecutive Hb measurements 110 gdL at any time during the study Falls activities of daily living ADLs and mobility will be assessed during the study Clinical laboratory results blood pressure and heart rate and the incidence and severity of adverse events will be monitored during the study
The study hypothesis is that the mean Hb change from baseline to the end of study will be significantly higher in the PROCRIT Epoetin alfa group over the control group Group 1 patients will receive a maximum of 13 doses of PROCRIT Epoetin alfa by subcutaneous injection under the skin for up to 26 weeks Dosage is based on the hemoglobin measurement done at each visit Doses will be started at an every 2-week interval and may be increased to every four weeks The maximum dose that can be given is 60000 Units of PROCRIT Epoetin alfa over a 4-week period Any PROCRIT Epoetin alfa dose over 40000 Units will be administered in two separate injections
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