Status:
COMPLETED
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Renal Failure
Tremors
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 conver...
Detailed Description
This is a 2 sequence, open-label, multicenter, prospective Phase 3b clinical study to access drug-induced hand tremors in stable kidney transplant subjects converted from Prograf (tacro-limus, Astella...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01438710
Start Date
December 1 2011
End Date
July 1 2015
Last Update
October 1 2015
Active Locations (10)
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1
Clinical Investigative Site 006
Los Angeles, California, United States, 90057
2
Clinical Investigative Site 1049
San Diego, California, United States, 92123
3
Clinical Investigative Site 007
Aurora, Colorado, United States, 80045
4
Clinical Investigative Site 005
New Haven, Connecticut, United States, 06520