Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus

NCT03703154 | Completed FDA Drug

• 1 other identifier: STUDY00142282
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn if conversion from immediate release tacrolimus to Envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Change in cognitive function using a battery of neuropsychological tests

  Battery aggregate scores include such tests as: Mini Mental Sate Exam, Montreal Cognitive Assessment, Digit Span, Logical Memory, Category Fluency, Trail Making, Digit Symbol, Block Design, Stroop, Buschke Free and Cued Reminding Test.

  Change from Baseline to Week 12

• Change in cerebral blood flow

  including brain blood flow response curve to exercise or cerebral reactivity

  Change from Baseline to Week 12

Study Arms (2)

Study Arm

The patients in the study arm will be converted from immediate release Tacrolimus to Envarsus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.

Drug: Envarsus

Control Arm

Patients in the control arm will remain on the immediate release Tacrolimus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.

Drug: Tacrolimus

Interventions

Envarsus DRUG

Patients will then be randomized in the ratio of 2:1 with 20 being in the study arm and 10 in the control arm. Envarsus will be prescribed by the transplant team per conversion guidelines. The transplant team will monitor drug levels, per the dosing guidelines.

Study Arm

Tacrolimus DRUG

The patient's physician will prescribe drug according to standard practice.

Also known as: Prograf

Control Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the KUMC kidney transplant clinic. Both male and female kidney transplant recipients aged 18 to 85 will be included.

You may qualify if:

• age between 18 and 85 years
• English speaking (NP tests will be in English);
• able to sign informed consent
• able to arrange transportation to and from study sites
• without acute stroke, concussion or traumatic brain injury
• received a kidney transplant at least 12 weeks before recruitment
• stable kidney function with serum creatinine \<3mg/dl

You may not qualify if:

• are claustrophobic or have other contra-indication for MRI
• have hearing or visual impairment
• are unable to read, write, speak or understand English
• have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
• dual organ transplant
• oxygen-dependent chronic obstructive pulmonary disease
• diagnosis of dementia
• unable to perform exercise on the Nustep (muscle weakness or cardiac safety concern)
• uncontrolled blood pressure

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 6 teaspoons of blood will be collected at each of the two visits and stored for future research (optional). This blood will be stored in the University of Kansas Kidney Institute Freezer.

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Aditi Gupta, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: October 11, 2018
• Study Start: October 25, 2018
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)