Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients

NCT ID: NCT03461445

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-07-31

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.

Conditions

Kidney Transplant; Complications; Toxicity; Drug Toxicity; Neurotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Envarsus

Patients will be converted to Envarsus formulation of tacrolimus

Group Type: EXPERIMENTAL

Envarsus

Intervention Type: DRUG

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

Immediate Release Tacrolimus

Patients will receive immediate release tacrolimus

Group Type: ACTIVE_COMPARATOR

IR Tacrolimus

Intervention Type: DRUG

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Interventions

Envarsus

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

Intervention Type: DRUG

IR Tacrolimus

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling-Xin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

UC Davis

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://studypages.com/s/an-experimental-comparison-study-of-envarsus-xr-and-tacrolimus-ir-for-elderly-kidney-transplant-patients-443391/

Learn more or sign up for the study here!

Other Identifiers

1044220

Identifier Type: -

Identifier Source: org_study_id