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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Toxicity Drug Toxicity Neurotoxicity Drug: Envarsus Drug: IR Tacrolimus Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Tremor
Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate Release Tacrolimus
Patients will receive immediate release tacrolimus
 Drug: IR Tacrolimus
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
Experimental: Envarsus
Patients will be converted to Envarsus formulation of tacrolimus
 Drug: Envarsus
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus


Outcome Measures
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Primary Outcome Measures :
  1. Change in neurocognitive side effects [ Time Frame: 6 weeks after randomization and baseline testing ]

Secondary Outcome Measures :
  1. Change in self-reported side effects [ Time Frame: 6 weeks after randomization and baseline testing ]
  2. Tacrolimus dose over concentration ratio [ Time Frame: 6 weeks after randomization and baseline testing ]
  3. Kidney graft survival [ Time Frame: 6 months after transplant ]
  4. Patient survival [ Time Frame: 6 months after transplant ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03461445


Contacts
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Contact: Ling-Xin Chen, MD 916.734.5141 lxchen@ucdavis.edu

Locations
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United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Ling-Xin Chen, MD    916-734-5141    lxchen@ucdavis.edu   
Sub-Investigator: Olivia Moss, RD         
Sub-Investigator: Golnaz Friedman, RD         
Sponsors and Collaborators
University of California, Davis
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Ling-Xin Chen, MD UC Davis
More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03461445    
Other Study ID Numbers: 1044220
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by University of California, Davis:
Elderly
Neurotoxicity
Calcineurin inhibitors
Tacrolimus
Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Tacrolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action