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NCT00445302 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
A Phase 1 study of Renal Impairment, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT00445302: Completed Phase 1 study of Renal Impairment, sponsored by Genzyme, a Sanofi Company.
NCT00445302 is a Phase 1 study of Renal Impairment that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 23 participants, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (32% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445302, a Phase 1 study of Renal Impairment, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study 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 enrolled and entered into three groups based on their renal function: Mild Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control subjects will have normal renal function. The screening visits will occur within 14 days prior to plerixafor administration on study day one. Subjects will be monitored for 10 hours following administration of the study drug. In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor administration for blood samples and safety assessments.
Primary Outcome
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.
Conditions Studied
Interventions
- DRUG plerixafor
Study Locations (3)
California
- Apex Research of Riverside - Santa Ana
Minnesota
- Prism Research, 1000 Westgate Dr. suite 149 - Saint Paul
Nebraska
- Creighton University Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
What the finished NCT00445302 record still lists
NCT00445302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which plerixafor is the first listed.
NCT00445302 reports a single indexed study location in California, Minnesota, Nebraska.
Frequently Asked Questions
What is clinical trial NCT00445302 about?
NCT00445302 is a clinical study titled "Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment". 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 enrolled and entered into three groups based on their renal function: Mild Impairment, Moderate Impairme...
What is the current status of trial NCT00445302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2006-01. Estimated completion is 2007-08.
What conditions does trial NCT00445302 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT00445302?
The interventions under investigation include: plerixafor (DRUG).
Who is sponsoring clinical trial NCT00445302?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00445302 being conducted?
This trial has 3 study locations across California, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00445302's enrollment target sits among peer trials
23 25th of 32 higher than 8 of 32 other Renal Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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