Kidney Transplant Recipients Clinical Trial
— SIMPLEOfficial title:
A Prospective, Randomized, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence & Patient Reported Symptom Occurrence & Interference w/ Daily Life Comparing Envarsus XR® & Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)
Verified date | November 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient is an adult (18 years of age or older). - Patient is a recipient of a deceased or living donor kidney transplant. - Patient is able to comply with study procedures for the entire length of the study. - Patient has been informed about the study survey and has signed an informed consent form. Exclusion Criteria: - Patient is unable or unwilling to complete study patient reported outcome questionnaires. - Patient is currently receiving azathioprine - Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus) - Patient is currently receiving an belatacept - Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant - Patient is in a setting where a professional care taker is responsible for dispensing subject's medication. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
United States | Mayo Clinic Arizona | Phoenix | Arizona |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Veloxis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. | The CIRS is a questionnaire that assesses five symptoms (from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]) that have been shown to be associated with calcineurin inhibitors. These symptoms include trembling hands, muscle cramps, muscle weakness, swollen gums, and increased hair growth. Each symptom is based on symptom severity in the last 7 days scaled from 0 (none) - 4 (very severe). The cumulative score ranges from 0-20. | 12 months | |
Secondary | Change in calcineurin inhibitor-related symptoms as measured by a change in the Calcineurin Inhibitor-Related Symptoms (CIRC) severity score. | The CIRS is a questionnaire that assesses five symptoms (from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]) that have been shown to be associated with calcineurin inhibitors. These symptoms include trembling hands, muscle cramps, muscle weakness, swollen gums, and increased hair growth. Each symptom is based on symptom severity in the last 7 days scaled from 0 (none) - 4 (very severe). The cumulative score ranges from 0-20. | 12 months | |
Secondary | Severity of calcineurin inhibitor-related symptoms | Total percent of patients in each treatment group with a severe or very severe score (3 or 4) on any CIRS item | 12 months | |
Secondary | Change in severity of calcineurin inhibitor-related symptoms | Total percent of patients with a reduction in a CIRS item score from a severe or very severe score (3 to 4) to a mild to moderate (1 or 2) score | From 4 to 12 months | |
Secondary | Change in any one calcineurin inhibitor-related symptom | Total percent of patients with a reduction in any single CIRS item by 1 point or greater | From 4 to 12 months. | |
Secondary | Change in transplant-related symptoms as measured by the difference in mean transplant-related symptoms (TRS) score. | The TRS is a multi-item questionnaire capturing 15 symptoms (from PRO-CTCAE) that have been shown to be associated with transplant and general health-related quality of life improvement. These symptoms include change in taste, constipation, diarrhea, swelling in arms or legs, palpitations, dry skin, darkening of skin, blurry vision, headache, insomnia, anxiety, sadness, discouraged, increase in appetite, and fatigue. Each symptom is based on symptom severity in the last 7 days and scaled from 0 (none) - 4 (very severe). Some symptoms also have added questions pertaining to frequency and/or interference with daily activities. | 12 months post-transplant | |
Secondary | Improvement in health-related qualify of life as measured by the PROMIS-29 health profile. | The PROMIS-29 produces individual scores for depression, anxiety, fatigue, pain interference, sleep disturbance, physical function, participation in social roles, and pain intensity. Physical and mental health summary scores will also be calculated. | 12 months post-transplant | |
Secondary | Change in individual transplant-related symptoms | Captured in the TRS questionnaire (individual TRS items will be classified as improved, worsened, unchanged) | 12 months post-transplant | |
Secondary | Change in overall tolerability or patient bother due to side effects | Measured by item GP5 ("I am bothered by side effects of treatment") from the FACT-G Questionnaire | 12 months post-transplant | |
Secondary | Change in mean taking adherence | Defined as the percentage of prescribed doses taken each day | 12 months post-transplant | |
Secondary | Change in patient medication satisfaction as assessed by question 14 of the Treatment Satisfaction Questionnaire for Medication. | Question 14 of the Treatment Satisfaction Questionnaire for Medication measures medication satisfaction on a 7 item scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied." | 12 months post-transplant | |
Secondary | Correlation between de novo DSA and degree of taking and timing adherence | Proportion of patients at different adherence thresholds of taking and timing adherences between 4 months and 12 months post transplant will be correlated with the presence or absence of dnDSA by 12 months post-transplant | 12 months post-transplant | |
Secondary | Adverse events | Number of adverse events reported | 12 months post-transplant |
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