Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment

This study has been completed.

Sponsor:

Information provided by:

Genzyme

ClinicalTrials.gov Identifier:

NCT00445302

First received: March 7, 2007

Last updated: December 12, 2010

Last verified: December 2010

History of Changes

Results First Received: December 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Renal Impairment
Intervention:	Drug: plerixafor

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Normal Renal Function	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.
Mild Renal Impairment	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.
Moderate Renal Impairment	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.
Severe Renal Impairment	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.

Participant Flow: Overall Study

	Normal Renal Function	Mild Renal Impairment	Moderate Renal Impairment	Severe Renal Impairment
STARTED	6	5	6	6
COMPLETED	6	5	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Normal Renal Function	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.
Mild Renal Impairment	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.
Moderate Renal Impairment	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.
Severe Renal Impairment	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	Total of all reporting groups

Baseline Measures

	Normal Renal Function	Mild Renal Impairment	Moderate Renal Impairment	Severe Renal Impairment	Total
Number of Participants [units: participants]	6	5	6	6	23
Age [units: years] Mean ± Standard Deviation	42.3 ± 5.50	56.2 ± 14.45	65.0 ± 5.83	55.7 ± 11.98	54.7 ± 12.51
Gender [units: participants]
Female	2	3	2	4	11
Male	4	2	4	2	12
Race/Ethnicity, Customized [units: participants]
Caucasian	1	3	3	5	12
African-American	4	1	2	1	8
Hispanic/Latino	1	1	1	0	3

Outcome Measures

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1. Primary:

Dose-Normalized Maximum Concentration of Plerixafor (Cmax) [ Time Frame: Pre-dose of plerixafor to 24 hours post-plerixafor ]

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2. Primary:

Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h) [ Time Frame: Pre-dose of plerixafor to 24 hours post-plerixafor ]

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3. Secondary:

Change From Baseline in Absolute CD34+ Cell Counts at Day 2 [ Time Frame: Baseline, Day 2 ]

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4. Secondary:

Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2 [ Time Frame: Baseline and Day 2 ]

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5. Secondary:

Number of Participants in Overall Safety Summary of Adverse Events (TEAE) [ Time Frame: up to Day 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
phone: 1-800-745-4447

No publications provided

Responsible Party:	Medical Monitor, Genzyme
ClinicalTrials.gov Identifier:	NCT00445302 History of Changes
Other Study ID Numbers:	AMD31001101
Study First Received:	March 7, 2007
Results First Received:	December 12, 2010
Last Updated:	December 12, 2010
Health Authority:	United States: Food and Drug Administration

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