Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)

Completed · Phase 3

Conditions studied: Renal Failure, Tremors

In brief

This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or generic tacrolimus

Key facts

Study ID

NCT01438710

Run by

Veloxis Pharmaceuticals

People needed

44

Starts

2011-12-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be able to give written consent
• Men and women between 18 and 65 years of age who are recipients of a kidney transplant between 1 month and 5 years prior to the screening date
• Subjects with at least one complaint of tremor and existence of postural tremor or action tremor on finger to nose as demonstrated by a score of at least 2 of any of the 4 upper extremity (UE) postural or action and intention assessments on the FTM clinical rating scale
• Subjects experiencing symptomatic drug-induced hand tremor associated with use of Prograf or generic tacrolimus as demonstrated by responding "no" to each of the following question: "Did you have a tremor that you noticed prior to starting Prograf or generic tacrolimus for your kidney transplant?", or "Are you aware of a tremor that runs in your family?"
• Subjects taking a stable dose of oral Prograf or generic tacrolimus capsules for at least 7 days with trough levels of tacrolimus between 3 to 12 ng/mL. Subjects must maintain tacrolimus trough levels in this range during the 7 day Prograf or generic tacrolimus treatment phase (note that 1 dose adjustment at Study Day 3 [a.m.dose] is allowed for those subjects whose Day0/1 trough level is out of range.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days before study start.

You may not qualify if…

• Recipients of any transplants including organ other than kidney and bone marrow
• Subjects with an estimated glomerular filtration rate (eGFR) (MDRD7) <30mL/min at Screening
• Subjects incapable of understanding the purposed and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with study protocol requirements
• Pregnant or nursing women
• Subjects with reproductive potential who are unwilling/unable to use a double barrier method of contraception
• Subjects who were treated with any other investigational agent within 3 months prior to screening
• Subjects who are taking drugs that are likely to affect the PK levels of tacrolimus and are not on a stable dose of those medications (see Appendix 1)
• Subjects who have essential tremor, Parkinsonism, or tremor from any cause other than tacrolimus-induced tremor;
• Subjects who are taking or had been taking any drug within the past 30 days that is well known to promote tremors, including: amiodarone, beta-agonist inhalers (such as albuterol), cyclosporine, lithium, metoclopramide, theophylline, or valproate,or taking within the past 6 months the dopamine blocking agents (antipsychotics) (note, other such medication may be considered on a case-by-case basis at the discretion of the investigator);
• Subjects who taking drugs that reduce tremor, and are not on stable doses of the treatment (ie, had not been taking the medication for a minimum of 30 days), including: gabapentin (note, other such medications may be considered on a case-by-case basis at the discretion of the investigator);
• Subjects on concurrent immunosuppression with MMD (CellCept) of MPS delayed-release tables (Myfortic), or generic versions of these medication, who have not been on stable doses at least 7 days prior to screening
• Subjects receiving prednisone or equivalent at a dose >10 mg per day
• Either subjects with an episode of acute rejection requiring treatment or subjects with an episode of biopsy-proven or suspected acute rejections that requires treatment within 3 months of screening
• Subjects who are being actively treated for cancer (with the exception of non-invasive basal cell or squamous cell) or human immunodeficiency virus (HIV)
• Subjects with any form of current drug or alcohol abuse

Where it is running

• Clinical Investigative Site 006 — Los Angeles, California, United States
• Clinical Investigative Site 1049 — San Diego, California, United States
• Clinical Investigative Site 007 — Aurora, Colorado, United States
• Clinical Investigative Site 005 — New Haven, Connecticut, United States
• Clinical Investigative Site 004 — Lexington, Kentucky, United States
• Clinical Investigative Site 008 — Minneapolis, Minnesota, United States
• Clinical Investigative Site 003 — St Louis, Missouri, United States
• Clinical Investigative Site 002 — Oklahoma City, Oklahoma, United States
• Clinical Investigative Site 009 — Nashiville, Tennessee, United States
• Clinical Investigative Site 012 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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