Status:
WITHDRAWN
Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus
Lead Sponsor:
Washington University School of Medicine
Conditions:
Peripheral Nerve Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Tacrolimus (FK506) is an immunosuppressive medication that promotes organ allograft survival. It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but these propert...
Eligibility Criteria
Inclusion
- have deficit of upper extremity function of MRC grade 0-2
- are candidates for surgical reconstruction
- are no more than 10 months after their injury
- have no ongoing infectious or wound healing complications related to injury or previous surgery or otherwise
- have no history of cancer or have been treated and free of cancer for at least 5 years
- age 18-50
- agree to participate in the study
Exclusion
- positive HIV or hepatitis blood test
- recent history of cancer within the past 5 years
- history of severe and recurrent infections (such as hidradenitis suppurativa)
- presence of ongoing and unresolved infectious concerns related to original injury or previous surgery (such as osteomyelitis, wound infection) or otherwise
- presence of ongoing wound healing problems related to the injury or previous surgery or otherwise
- presence of moderate or severe liver disease as indicated by aspartate transaminase (AST), alanine transaminase (ALT), amino alkaline phosphatase, or total bilirubin levels greater than the upper limit of normal (ULN)
- creatinine level ≥ 1.0 mg/dl or more than ULN
- hemoglobin value of \<9.0 mg/dl, a white blood cell count \<3,000 cells/mm3, or platelet count \<100,000 platelets/mm3
- uncontrolled hypertension with systolic blood pressure \>160 mm Hg and diastolic blood pressure \>90 mm Hg at screening and baseline
- hyperkalemia (serum K \> ULN)
- pancreatitis or diabetes mellitus (fasting blood sugar ≥ 110 mg/dl or postprandial blood sugar ≥ 160 mg/dl) or a history of these
- heart disease or abnormal electrocardiogram (ECG) especially arrhythmia and change in ST/T or a previous history of these
- history of serious drug hypersensitivity
- age less than 18 or greater than 50
- incarceration prior to or at the time of consideration for enrollment (any participant who becomes incarcerated during the course of the study will be excluded)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00950391
Start Date
August 1 2010
End Date
September 1 2015
Last Update
February 13 2018
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