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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438710
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : May 8, 2015
Last Update Posted : October 1, 2015
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

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 conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or generic tacrolimus

Condition or disease Intervention/treatment Phase
Renal Failure Tremors Drug: Prograf Drug: LCP-Tacro Phase 3

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, Astellas Pharma US, Inc., Deerfield, IL) or generic tacrolimus twice daily (b.i.d.) to LCP-Tacro tablets (tacrolimus, Veloxis Pharmaceuticals A/S, Horsholm, Denmark) once daily (q.d.). The trial is designed to determine if the test drug LCP-Tacro, is associated with fewer and/or less severe drug-induced hand tremor than observed with Prograf or generic tacrolimus treatment; each therapy is to be concomitantly administered with mycophenolate mofetil (MMF), mycophenolate sodium (MPS), including generic versions of each, and/or prednisone or equivalent as long as doses remain stable during the study. All prophylaxis and other medication will be allowed per standard of care (SOC) in each of the participating sites; no medication that interacts with the pharmacokinetics (PK) of tacrolimus is allowed unless subjects who are recipients of a renal transplant at least 1 month and not more than 5 years prior to enrollment. Following screening, study visits will be conducted over a 2-week treatment period with consists of 1 week of Prograf or generic tacrolimus SOC, and 1 week of LCP-Tacro. Subjects who qualify for extended use of LCP-Tacro can continue LCP-Tacro treatment for additional 2 years. This decision will be made at the discretion of the physician and subject.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: LCP-Tacro
LCP Tacro tables for once daily oral administration
Drug: LCP-Tacro
LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
Other Name: tacrolimus

Experimental: Prograf
Tacrolimus capsules for twice daily oral administration
Drug: Prograf
Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
Other Name: tacrolimus

Primary Outcome Measures :
  1. Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. [ Time Frame: 14 days ]

    The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion.

    The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor.

    Below the mean total score and standard deviation for each treatment is given in addition to the mean change.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be able to give written consent
  2. 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
  3. 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
  4. 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?"
  5. 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.
  6. Women of childbearing potential must have a negative serum pregnancy test within 7 days before study start.

Exclusion Criteria:

  1. Recipients of any transplants including organ other than kidney and bone marrow
  2. Subjects with an estimated glomerular filtration rate (eGFR) (MDRD7) <30mL/min at Screening
  3. 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
  4. Pregnant or nursing women
  5. Subjects with reproductive potential who are unwilling/unable to use a double barrier method of contraception
  6. Subjects who were treated with any other investigational agent within 3 months prior to screening
  7. 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)
  8. Subjects who have essential tremor, Parkinsonism, or tremor from any cause other than tacrolimus-induced tremor;
  9. 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);
  10. 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);
  11. 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
  12. Subjects receiving prednisone or equivalent at a dose >10 mg per day
  13. 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
  14. Subjects who are being actively treated for cancer (with the exception of non-invasive basal cell or squamous cell) or human immunodeficiency virus (HIV)
  15. Subjects with any form of current drug or alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438710

United States, California
Clinical Investigative Site 006
Los Angeles, California, United States, 90057
Clinical Investigative Site 1049
San Diego, California, United States, 92123
United States, Colorado
Clinical Investigative Site 007
Aurora, Colorado, United States, 80045
United States, Connecticut
Clinical Investigative Site 005
New Haven, Connecticut, United States, 06520
United States, Kentucky
Clinical Investigative Site 004
Lexington, Kentucky, United States, 40536
United States, Minnesota
Clinical Investigative Site 008
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Clinical Investigative Site 003
St Louis, Missouri, United States, 63110
United States, Oklahoma
Clinical Investigative Site 002
Oklahoma City, Oklahoma, United States, 73112
United States, Tennessee
Clinical Investigative Site 009
Nashiville, Tennessee, United States, 37232
United States, Texas
Clinical Investigative Site 012
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Veloxis Pharmaceuticals
Study Director: Alan Glicklich, MD VP, Clinical Development

Responsible Party: Veloxis Pharmaceuticals Identifier: NCT01438710     History of Changes
Other Study ID Numbers: LCP-Tacro 3003
First Posted: September 22, 2011    Key Record Dates
Results First Posted: May 8, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action