Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients

Completed · Not applicable

Conditions studied: Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence

In brief

There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings. This pilot study is to: 1. Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled. 2. Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study 3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study 4. Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study 5. Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients

Key facts

Study ID

NCT02763943

Run by

Medical University of South Carolina

People needed

60

Starts

2016-04-01

Expected to finish

2018-01-22

Last updated by the study team

2018-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age and able to give informed consent.
• Received a first or repeat cadaveric or living donor renal transplant.
• Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
• Patient is at least one year post transplant.
• Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
• Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
• Willing to comply with all study visits.

You may not qualify if…

• Biopsy proven acute rejection episode that occurred within the past month.
• Patients who have received an organ transplant other than a kidney.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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