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Trial record 1 of 1 for:    AMD31001101
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Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment

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ClinicalTrials.gov Identifier: NCT00445302
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : January 12, 2011
Last Update Posted : March 13, 2014
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Impairment
Intervention Drug: plerixafor
Enrollment 23
Recruitment Details  
Pre-assignment Details Cohort enrollment into the study was staged based on baseline creatinine clearance levels, with moderate renal impairment and control participants enrolled first. Severe renal impairment were enrolled following completion of the moderate renal impairment. Participants with mild renal impairment were enrolled last.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Period Title: Overall Study
Started 6 5 6 6
Completed 6 5 6 6
Not Completed 0 0 0 0
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment Total
Hide Arm/Group Description Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Total of all reporting groups
Overall Number of Baseline Participants 6 5 6 6 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 6 participants 6 participants 23 participants
42.3  (5.50) 56.2  (14.45) 65.0  (5.83) 55.7  (11.98) 54.7  (12.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 6 participants 6 participants 23 participants
Female
2
  33.3%
3
  60.0%
2
  33.3%
4
  66.7%
11
  47.8%
Male
4
  66.7%
2
  40.0%
4
  66.7%
2
  33.3%
12
  52.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 6 participants 6 participants 23 participants
Caucasian 1 3 3 5 12
African-American 4 1 2 1 8
Hispanic/Latino 1 1 1 0 3
1.Primary Outcome
Title Dose-Normalized Maximum Concentration of Plerixafor (Cmax)
Hide Description Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.
Time Frame Pre-dose of plerixafor to 24 hours post-plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Overall Number of Participants Analyzed 6 5 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL/ug
0.0452  (0.0145) 0.0388  (0.0095) 0.0490  (0.0150) 0.0475  (0.0110)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means (%)
Estimated Value 87.09
Confidence Interval (2-Sided) 90%
63.59 to 119.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means(%)
Estimated Value 106.60
Confidence Interval 90%
78.99 to 143.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means (%)
Estimated Value 106.76
Confidence Interval 90%
79.11 to 144.08
Estimation Comments [Not Specified]
2.Primary Outcome
Title Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)
Hide Description Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.
Time Frame Pre-dose of plerixafor to 24 hours post-plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Overall Number of Participants Analyzed 6 5 6 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL/ug
0.2277  (0.0360) 0.2866  (0.0854) 0.3550  (0.0965) 0.3872  (0.0688)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means (%)
Estimated Value 121.74
Confidence Interval 90%
91.86 to 161.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means (%)
Estimated Value 151.44
Confidence Interval 90%
115.78 to 198.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of least squares means (%)
Estimated Value 169.51
Confidence Interval 90%
129.59 to 221.72
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Absolute CD34+ Cell Counts at Day 2
Hide Description Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat approach was used to calculate the outcome measure in each arm/group.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Overall Number of Participants Analyzed 6 5 6 6
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
10.5  (6.19) 11.8  (2.49) 14.3  (14.24) 23.0  (18.20)
4.Secondary Outcome
Title Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2
Hide Description Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.
Time Frame Baseline and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat approach was used to calculate the outcome measure in each arm/group.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Overall Number of Participants Analyzed 6 5 6 6
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
7416.7  (1986.37) 10540.0  (2785.32) 12133.3  (4501.41) 14975.0  (5030.82)
5.Secondary Outcome
Title Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
Hide Description Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Time Frame up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
Overall Number of Participants Analyzed 6 5 6 6
Measure Type: Number
Unit of Measure: participants
AE Severity (Mild) 3 1 3 2
AE Severity (Moderate) 2 1 1 2
AE Severity (Severe) 0 0 0 0
AE Severity (Life Threatening) 0 0 0 0
AE Relationship to Drug (Definitely related) 4 2 2 2
AE Relationship to Drug (Probably related) 1 0 2 0
AE Relationship to Drug (Possibly related) 0 0 0 2
AE Relationship to Drug (Probably not related) 0 0 0 0
AE Relationship to Drug (Definitely not related) 0 0 0 0
Time Frame From the time of the first dose of plerixafor to study Day 3 (study completion).
Adverse Event Reporting Description

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Each AE table includes events, regardless of reported relationship to study treatment or grade.

 
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
All-Cause Mortality
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/5 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   4/6 (66.67%)   2/5 (40.00%)   5/6 (83.33%) 
Blood and lymphatic system disorders         
Leukocytosis  1 [1]  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  2/6 (33.33%)  0/6 (0.00%)  2/5 (40.00%)  2/6 (33.33%) 
Hypoaesthesia oral  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Nausea  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  2/6 (33.33%) 
Vomiting  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
General disorders         
Feeling hot  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Injection site bruising  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Injection site erythema  1  1/6 (16.67%)  1/6 (16.67%)  1/5 (20.00%)  2/6 (33.33%) 
Injection site rash  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Injection site reaction  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
Investigations         
Red blood cells urine positive  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Urinary sediment present  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Urine analysis abnormal  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
White blood cell count increased  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
White blood cells urine positive  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
Nervous system disorders         
Dizziness  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
Dysgeusia  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Headache  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
Paraesthesia  1  2/6 (33.33%)  0/6 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
Sinus headache  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Psychiatric disorders         
Insomnia  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Hyperventilation  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Hyperhidrosis  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Pruritus  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%) 
Vascular disorders         
Flushing  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
Phlebitis  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
This event of leukocytosis reflects a white blood cell (WBC) count of 26.44*10^9/L.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after Genzyme publishes or 12 months after study completion. PI gives Genzyme a draft 30 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 90 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 1-800-745-4447
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00445302    
Other Study ID Numbers: AMD31001101
First Submitted: March 7, 2007
First Posted: March 8, 2007
Results First Submitted: December 12, 2010
Results First Posted: January 12, 2011
Last Update Posted: March 13, 2014