- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00109291
Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease
December 19, 2012 updated by: Affymax
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment
To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This was a Phase 2a, randomized, double-blind, placebo-controlled, sequential dose escalation study conducted at a single clinical center.
The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort.
In each treatment cohort, participants were randomly assigned to receive either a single dose of peginesatide (n=7 in the first cohort, n=4 in subsequent cohorts) or placebo (n=2 in the first cohort, n=1 in subsequent cohorts).
Participants were followed for a minimum of 28 days.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Research Facility
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines;
- Males or females ≥ 18 and ≤ 75 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice an adequate form of contraception for at least 2 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after receiving study drug;
- Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60 milliliter per minute (mL/min) within 28 days prior to administration of study drug,) not requiring dialysis;
- Two hemoglobin values of ≥ 9 grams per deciliter (g/dL) and ≤ 11 g/dL within 14 days prior to administration of study drug, with one of the values drawn within 7 days prior to administration of study drug;
- One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin saturation ≥ 20% within 28 days prior to administration of study drug;
- One serum folate level above the lower limit of normal within 28 days prior to administration of study drug;
- One vitamin B12 level above the lower limit of normal within 28 days prior to administration of study drug;
- Weight ≥ 45 kg within 28 days prior to administration of study drug;
- One white blood cell count ≥ 3.0 x 10^9/L within 28 days prior to administration of study drug; and
- One platelet count ≥ 140 x 10^9/L and ≤ 500 x 10^9/L within 28 days prior to administration of study drug.
Exclusion Criteria:
- Prior treatment with any erythropoiesis stimulating agent;
- History of pure red cell aplasia;
- Red blood cell transfusion within 3 months prior to study drug administration;
- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
- Hemolysis based on medical judgment;
- Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
- C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration of study drug;
- Significant infection within 4 weeks prior to study drug administration, per Investigator's clinical judgment ;
- Febrile illness within 7 days prior to administration of study drug;
- Uncontrolled or symptomatic secondary hyperparathyroidism;
- Poorly controlled hypertension within 4 weeks prior to study drug administration, per Investigator's clinical judgment (e.g. systolic ≥ 170mm Hg, diastolic ≥ 100 mm Hg on repeat readings);
- Epileptic seizure in the 6 months prior to study drug administration;
- Chronic congestive heart failure (New York Heart Association Class IV);
- High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions within the past 6 months that may, in the Investigator's opinion, interfere with assessment or follow-up of the patient);
- Malignancy (except non-melanoma skin cancer);
- Life expectancy < 12 months;
- Anticipated elective surgery during the study period;
- Previous exposure to any investigational agent within 4 months prior to administration of study drug or planned receipt during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Single injection of placebo administered intravenously
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Experimental: Peginesatide 0.025 mg/kg
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
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Other Names:
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Experimental: Peginesatide 0.05 mg/kg
Single peginesatide dose of 0.05 mg/kg administered intravenously.
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Other Names:
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Experimental: Peginesatide 0.10 mg/kg
Single peginesatide dose of 0.10 mg/kg administered intravenously.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events and serious adverse events
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters
Time Frame: 28 days
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Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-∞, t½ß, Vd, Vss, and Cl
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28 days
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Pharmacodynamic parameters
Time Frame: 28 days
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Pharmacodynamic parameters including reticulocytes, hemoglobin, reticulocyte hemoglobin content, and serum measures of iron stores (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein)
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Affymax, Affymax, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
April 27, 2005
First Submitted That Met QC Criteria
April 26, 2005
First Posted (Estimate)
April 27, 2005
Study Record Updates
Last Update Posted (Estimate)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 19, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFX01-02
- 2005-000125-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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