An Experimental Comparison Study of Envarsus ® XR and Tacrolimus IR for Elderly Kidney Transplant Patients

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"This study will test any differences in neurological side effects between two FDA indicated medications to prevent rejection of your kidney."
Age: 65 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: kidney transplant, neurological side effects, memory, tremor, cognition
Type: Drug study, Phase 4
Target:
60 Participants
Investigator:
Description
If you recently had a kidney transplant and are over the age of 65, you may qualify to take part in this research study.

This study will test the differences in side effects between two FDA-approved medications. These medications aim to prevent rejection of your kidney. The side effects studied may include tremor, memory, and cognition. We will look to see if there are any changes in these side effects over a period of 6 weeks. Both medications are proven to be safe and effective to prevent organ rejection. We are interested in learning if there may be a difference between side effects in patients over 65 years of age.
This study requires

You will be in this study for 6 weeks. You will either stay on your current anti-rejection medications or it will be changed to include Envarsus ® XR. You will have two additional study visits compared to if you were not to participate in this study.

During these visits we will ask you some questions to assess neurological side effects. These questions will be provided in the form of a written questionaire. These visits will occur at the start of your study participation (Wk 0-1) and at the end of your study participation (Wk 6-8).

These visits will be about one hour each. During these visits you will interact with the study doctor, nurse or coordinator. The research will be conducted at the UC Davis Health campus. Whether or not you choose to participate in this study, you will continue to be followed by your Transplant team with lab draws and clinic appointments as indicated.

If you are placed on Envarsus XR ® and choose to remain on the medication at the of the 6 week study, you may discuss that with your doctor. We may contact you in the future to see if you would be interested in participating long term follow up study for patients on this medication.

The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given each treatment.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you or others from your taking part in this research.

RISKS:

The study doctor will discuss any risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you a total of $40 for your time and effort. You will receive $20 upon enrollment and $20 at the completion of your 6 week study period.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 6 weeks.
Recruitment period
From Feb. 22, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Macey Sockolov
Research Topic
Conditions:
  • Kidney Transplant; Complications
  • Toxicity
  • Drug Toxicity
  • Neurotoxicity

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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