NCT06023615

MITIGAAT: Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants

Active, Not Recruiting
NAAges 18+InterventionalPrevention
Medical University of South Carolina
~190 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:mHealth app/dashboard

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Medication Adherence
Measured over 2 Years
+5 more outcomes measured
Medication Adherence
Medication Compliance
1 sites across 1 states
South Carolina1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

≥18 years of age
≥2 years post-kidney transplant

Exclusion

Non-kidney transplant recipient (liver, lung, heart, intestine, pancreas, bone marrow)
Not capable of measuring own BP and glucose in those with diabetes
Not capable of using mobile health application after adequate training
Not capable of speaking, hearing, and reading English
  • Medication Adherence2 Years

    Medication adherence will be measured by using tacrolimus trough concentration variability, which is a validated proxy measure of medication adherence. This is defined as the intrapatient tacrolimus concentration coefficient of variation (CV): standard deviation divided by the mean for each patient. All outpatient true trough tacrolimus levels drawn will be used to calculate the tacrolimus CV. This will be assessed every 3 months, which aligns with the minimum lab draw schedule for kidney transplant recipients at out center. This will be analyzed using repeated measures methodology, estimating efficacy effect size using the time\*treatment interaction term and disparity using the time\*treatment\*race interaction term.

  • Blood Pressure2 Years

    Blood pressure control will be defined as the mean of all systolic BPs checked by patients at home and the transplant center (ambulatory measures). Patients with a mean of SBP ≤140 mmHg will be considered controlled. We will aggregate and assess blood pressure levels every month (25 total); analyzed using repeated measures (time\*treatment and disparity using the time\*treatment\*race interaction term).

  • Glucose Control2 Years

    Glucose control is defined as the mean measure of all glucoses (random or fasting). Those with DM and a mean random glucose ≤160 mg/dL will be considered to controlled. We will aggregate and assess glucose levels every month (25 total); analyzed using repeated measures (time\*treatment and disparity using the time\*treatment\*race interaction term).

  • Cost-Benefit Analysis2 Years

    Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED visit costs in the intervention arm vs the control arm and compare this to the costs needed to deliver the intervention.

  • Acute Rejection2 Years

    This is defined as the proportion of patients in each arm with a renal allograft biopsy showing at least grade 1A rejection by Banff criteria. Per usual care practices, all patients are required to have biopsy confirmation of rejection episodes within 24 hours of onset of treatment for acute rejection. It is standard care that all kidney allograft biopsies performed for transplant recipients occur at the transplant center (study institution). Biopsies will be read by a blinded local pathologist, as usual care. This will be assessed using time to event analyses..

  • Graft Failure2 Years

    This is defined as the proportion of patients in each arm with graft failure, which is a composite outcome of either return to chronic dialysis, nephrectomy, re-transplant, or death. The timing and cause of each graft loss will be recorded for comparative analysis.