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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461445
• Other study ID #: 1044220
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Recipient of a kidney transplant

2. Age 60 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

Related Conditions & MeSH terms

• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Kidney Transplant; Complications
• Neurotoxicity
• Neurotoxicity Syndromes
• Toxicity

Intervention

Drug:
• Envarsus
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
• IR Tacrolimus
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Locations

Country	Name	City	State
United States	UC Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neurocognitive side effects		6 weeks after randomization and baseline testing
Secondary	Change in self-reported side effects		6 weeks after randomization and baseline testing
Secondary	Tacrolimus dose over concentration ratio		6 weeks after randomization and baseline testing
Secondary	Kidney graft survival		6 months after transplant
Secondary	Patient survival		6 months after transplant

External Links

•   Learn more or sign up for the study here!