Chronic Kidney DiseasePhase 1NCT00641589
A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease
A Phase 1 study testing epoetin alfa in people with Chronic Kidney Disease and Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Anemia
- What is being tested?
- epoetin alfa
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a Glomerular Filtration Rate (GFR) within 15-60 mL/min/1.73m2 and stable creatinine over the past 6 months and no expected need for dialysis during the study
- Patients with a hemoglobin (Hg) < 11 g/dL at Screening
- Patients with a transferrin saturation >= 20% or a ferritin >= 50 ng/mL.
- Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose
- Patients with reproductive potential must have a negative B-HCG pregnancy test within 14 days of the first dose of study drug and a negative urine pregnancy test on the day of the first dose of study drug
- Patients and their partners must be practicing an effective method of birth control before entry and throughout the study
Who cannot join
- Exclusion criteria include but are not limited to the following: Patients with significant hematological disease (disorders of the blood and blood forming tissues
- including but not limited to myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy)
- Patients with liver function test results > 2 or more times the normal value
- Patients with new onset seizures (within the last 3 months) or seizures not controlled by medication prior to admission in to the study
- Patients with a history of thrombotic vascular events (including by not limited to acute myocardial infarction (AMI) within the previous 6 months, stroke, transient ischemic attack (TIA), deep vein thrombosis,(DT) and pulmonary embolism (PE)
- Patients with poorly controlled or uncontrolled hypertension
- Patients with anemia due to blood loss.
About this study
Official title: An Open-Label, Randomized Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Subjects With Chronic Kidney Disease
The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD).
Read the detailed description
This is a prospective, open-label (both the patient and the physician know the drug and drug dose being given), randomized (patients are assigned to a dosing regimen by chance), multicenter, pharmacokinetic study in patients with anemia secondary to non-dialysis chronic kidney disease (CKD). A pharmacokinetic study is one that evaluates the process by which a drug is utilized by the body.
Approximately 40 patients will participate in this study. This study has 3 Phases; the Screening Phase, the Open-Label Treatment Phase and Study Completion/Early Withdrawal Phase. In the Screening Phase, patients may be evaluated up to 14 days before study entry. The Treatment Phase begins when the patient is randomly assigned to a treatment group and continues until the patient has received the last dose of study drug. The Study Completion/Early Withdrawal Phase is the phase during which the last study-related procedures take place. This Phase should occur on Study Day 64 for the Q4W group and on Study Day 36 for all other dosing regimens. Patients who satisfy all study inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to one of four treatment groups. Dosing will continue through Study Day 26 for treatment group A, through Study Day 22 for treatment group B, through Study Day 15 for treatment group C, and through Study Day 29 for treatment group D. No dose escalation or dose reductions are allowed during the study. Safety will be monitored by physical examinations, vital signs, clinical laboratory tests, and the occurrence and severity of any adverse events. Safety monitoring will continue through 30 days after the last visit for all treatment groups.
Pharmacokinetic and pharmacodynamic (the study of the action or effects of drugs on the body) sampling will occur throughout the study. A patient evaluable for pharmacokinetic and pharmacodynamic parameters is one who receives the first scheduled dose of the assigned study drug, has at least 75% of the pharmacokinetic samples collected up to and including Day 29 for all groups, and does not receive any red blood cell (RBC) transfusions prior to Study Day 8. Pharmacokinetic evaluations will continue through Study Day 29 for groups A, B, C; through Study Day 57 for Group D, and will include but are not limited to: maximal serum concentrations of erythropoietin, time to reach maximal serum concentration and time for erythropoietin to be eliminated from the body. Pharmacodynamic evaluations continue through Study Day 36 for Groups A,B,C; through Study Day 64 for Group D, and will include but are not limited to hemoglobin (Hg), hematocrit (Hct), total red blood cell (RBC) count. The primary objective of this study is to describe the pharmacokinetic profiles of four different dosing regimens of PROCRIT (epoetin alfa) in patients with anemia secondary to non-dialysis chronic kidney disease (CKD).
The secondary objective is to describe the pharmacodynamic response to the four epoetin alfa study dosing regimens. Patients will be randomly assigned to one of four dosing regimens of epoetin alfa: Group A: 50 IU (International Units)/kilogram (kg) three times per week (TIW); Group B: 10,000 IU once weekly (QW); Group C: 20,000 IU every 2 weeks (Q2W); and Group D: 40,000 IU every 4 weeks (Q4W).
- Conditions
- Chronic Kidney Disease, Anemia
- Being tested
- epoetin alfa
- Keywords
- Chronic Kidney Disease, anemia, epoetin alfa
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
Secondary outcomes (1)
The secondary objective is to describe the pharmacodynamic (PD) response to the four PROCRIT study dosing regimens using the following outcomes: absolute and % reticulocyte count, hemoglobin (Hb), hematocrit (Hct), and red blood cell (RBC) count.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641589
- Sponsor's protocol ID
- CR002299
- Status last verified
- Apr 2010
- First submitted
- 17 Mar 2008
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Subjects With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00641589
- Acronym / sponsor ID
- CR002299
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Chronic Kidney Disease, anemia, epoetin alfa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Jan 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD).
Detailed description
This is a prospective, open-label (both the patient and the physician know the drug and drug dose being given), randomized (patients are assigned to a dosing regimen by chance), multicenter, pharmacokinetic study in patients with anemia secondary to non-dialysis chronic kidney disease (CKD). A pharmacokinetic study is one that evaluates the process by which a drug is utilized by the body.
Approximately 40 patients will participate in this study. This study has 3 Phases; the Screening Phase, the Open-Label Treatment Phase and Study Completion/Early Withdrawal Phase. In the Screening Phase, patients may be evaluated up to 14 days before study entry. The Treatment Phase begins when the patient is randomly assigned to a treatment group and continues until the patient has received the last dose of study drug. The Study Completion/Early Withdrawal Phase is the phase during which the last study-related procedures take place. This Phase should occur on Study Day 64 for the Q4W group and on Study Day 36 for all other dosing regimens. Patients who satisfy all study inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to one of four treatment groups. Dosing will continue through Study Day 26 for treatment group A, through Study Day 22 for treatment group B, through Study Day 15 for treatment group C, and through Study Day 29 for treatment group D. No dose escalation or dose reductions are allowed during the study. Safety will be monitored by physical examinations, vital signs, clinical laboratory tests, and the occurrence and severity of any adverse events. Safety monitoring will continue through 30 days after the last visit for all treatment groups.
Pharmacokinetic and pharmacodynamic (the study of the action or effects of drugs on the body) sampling will occur throughout the study. A patient evaluable for pharmacokinetic and pharmacodynamic parameters is one who receives the first scheduled dose of the assigned study drug, has at least 75% of the pharmacokinetic samples collected up to and including Day 29 for all groups, and does not receive any red blood cell (RBC) transfusions prior to Study Day 8. Pharmacokinetic evaluations will continue through Study Day 29 for groups A, B, C; through Study Day 57 for Group D, and will include but are not limited to: maximal serum concentrations of erythropoietin, time to reach maximal serum concentration and time for erythropoietin to be eliminated from the body. Pharmacodynamic evaluations continue through Study Day 36 for Groups A,B,C; through Study Day 64 for Group D, and will include but are not limited to hemoglobin (Hg), hematocrit (Hct), total red blood cell (RBC) count. The primary objective of this study is to describe the pharmacokinetic profiles of four different dosing regimens of PROCRIT (epoetin alfa) in patients with anemia secondary to non-dialysis chronic kidney disease (CKD).
The secondary objective is to describe the pharmacodynamic response to the four epoetin alfa study dosing regimens. Patients will be randomly assigned to one of four dosing regimens of epoetin alfa: Group A: 50 IU (International Units)/kilogram (kg) three times per week (TIW); Group B: 10,000 IU once weekly (QW); Group C: 20,000 IU every 2 weeks (Q2W); and Group D: 40,000 IU every 4 weeks (Q4W).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a Glomerular Filtration Rate (GFR) within 15-60 mL/min/1.73m2 and stable creatinine over the past 6 months and no expected need for dialysis during the study
- Patients with a hemoglobin (Hg) < 11 g/dL at Screening
- Patients with a transferrin saturation >= 20% or a ferritin >= 50 ng/mL.
- Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose
- Patients with reproductive potential must have a negative B-HCG pregnancy test within 14 days of the first dose of study drug and a negative urine pregnancy test on the day of the first dose of study drug
Key exclusion criteria (7 listed)
- Exclusion criteria include but are not limited to the following: Patients with significant hematological disease (disorders of the blood and blood forming tissues
- including but not limited to myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy)
- Patients with liver function test results > 2 or more times the normal value
- Patients with new onset seizures (within the last 3 months) or seizures not controlled by medication prior to admission in to the study
- Patients with a history of thrombotic vascular events (including by not limited to acute myocardial infarction (AMI) within the previous 6 months, stroke, transient ischemic attack (TIA), deep vein thrombosis,(DT) and pulmonary embolism (PE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
1 secondary outcome
The secondary objective is to describe the pharmacodynamic (PD) response to the four PROCRIT study dosing regimens using the following outcomes: absolute and % reticulocyte count, hemoglobin (Hb), hematocrit (Hct), and red blood cell (RBC) count.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- An open-label, randomized study to deteremine the pharmacokinetic and pharmacodynamic profiles of PROCRIT (Epoetin alfa) in anemic subjects with chronic kidney diseaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epoetin alfa in people with Chronic Kidney Disease and Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.