Status:
COMPLETED
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Renal Impairment
Eligibility:
All Genders
18-78 years
Phase:
PHASE1
Brief Summary
Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal impairment will be enro...
Detailed Description
This is a phase I, open label, multi-center study in which up to eighteen subjects with renal impairment and six healthy control subjects with normal renal function will receive a single dose of pleri...
Eligibility Criteria
Inclusion
- Signed patient informed consent form prior to any study procedures at Screening.
- Subject has not consumed alcohol in the 48 hours prior to the administration of study drug.
- Subject agrees to refrain from consumption of alcohol for the duration of the trial.
- Subject agrees to practice an approved method of contraception for the duration of the study.
- White blood cell count ≧3.5\*10\^9/L.
- Absolute polymorphonuclear leukocyte count \>2.5\*10\^9/L.
- Platelet count \>125\*10\^9/L.
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 times upper limit of normal (ULN).
- Negative for Human Immunodeficiency Virus (HIV).
- Age: Renal impairment subjects, 18-78 years. Control subjects, 35-78 years.
- Creatinine clearance measured from 24-hour urine collection (CLcr u): Renal impairment cohorts, Mild Impairment (CLcr u = 51-80 ml/min), Moderate Impairment (CLcr u = 31-50 ml/min), and Severe Impairment (CLcr u \<31 ml/min, not requiring dialysis). Control subjects, CLcr u \>90 ml/min.
Exclusion
- Known sensitivity to plerixafor or any of its components.
- Pregnant or breast-feeding.
- Actual body weight exceeds 175% of ideal body mass index.
- Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol.
- Any subject who has started new medication within 14 days prior to study drug administration.
- Treatment with an investigational product within 30 days prior to trial entry.
- Any significant untreated or newly diagnosed medical condition other than renal impairment that in the opinion of the investigator may interfere with the conduct of the study.
- Abnormal electrocardiogram with clinically significant rhythm disturbance,(ventricular arrhythmias), or other conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial.
- History of clinically significant thrombocytopenia.
- Received blood transfusions within 30 days prior to trial entry.
- Any subject who requires therapeutic intervention within the 30 days prior to administration of study medication in order to meet the inclusion/exclusion criteria.
- Active malignant/neoplastic disease requiring treatment of any kind.
- Active infection requiring antibiotics
- Renal impairment requiring any method of dialysis
- History of kidney transplant
- Subjects having clinical status or laboratory parameter deterioration between the time of enrollment and dosing with plerixafor (such that they no longer meet entry criteria) may be removed from the study at the discretion of the treating physician, principal investigator, or sponsor.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00445302
Start Date
January 1 2006
End Date
August 1 2007
Last Update
March 13 2014
Active Locations (3)
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1
Apex Research of Riverside
Santa Ana, California, United States, 92705
2
Prism Research, 1000 Westgate Dr. suite 149
Saint Paul, Minnesota, United States, 55114
3
Creighton University Medical Center
Omaha, Nebraska, United States, 68131