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A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients

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ClinicalTrials.gov Identifier: NCT03461445
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
Change in neurocognitive side effects [ Time Frame: 6 weeks after randomization and baseline testing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Change in self-reported side effects [ Time Frame: 6 weeks after randomization and baseline testing ]
  • Tacrolimus dose over concentration ratio [ Time Frame: 6 weeks after randomization and baseline testing ]
  • Kidney graft survival [ Time Frame: 6 months after transplant ]
  • Patient survival [ Time Frame: 6 months after transplant ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Official Title  ICMJE A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Brief Summary Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
Detailed Description The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplant; Complications
  • Toxicity
  • Drug Toxicity
  • Neurotoxicity
Intervention  ICMJE
  • Drug: Envarsus
    Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
  • Drug: IR Tacrolimus
    Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
Study Arms  ICMJE
  • Active Comparator: Immediate Release Tacrolimus
    Patients will receive immediate release tacrolimus
    Intervention: Drug: IR Tacrolimus
  • Experimental: Envarsus
    Patients will be converted to Envarsus formulation of tacrolimus
    Intervention: Drug: Envarsus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Recipient of a kidney transplant
  2. Age 65 or greater at the time of transplant
  3. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
  4. Have IR tacrolimus as maintenance therapy
  5. Have BMI < 35 at time of transplant
  6. Achieve therapeutic tacrolimus level within 4 weeks post-transplant

Exclusion Criteria:

  1. Recipient of a simultaneous non-kidney transplant (pancreas)
  2. Had an episode of rejection before study enrollment
  3. Had a TIA/CVA after transplantation and before study enrollment
  4. Had a neurologic injury after transplantation and before study enrollment
  5. Blindness
  6. Have an mTOR inhibitor as maintenance therapy
  7. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
  8. Adults unable to consent
  9. Pregnant women
  10. Prisoners
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ling-Xin Chen, MD 916.734.5141 lxchen@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03461445
Other Study ID Numbers  ICMJE 1044220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Veloxis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Ling-Xin Chen, MD UC Davis
PRS Account University of California, Davis
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP