Cardiovascular Risk Following Conversion to Full Dose Myfortic® & Neoral®

Status Withdrawn

Clinical Trial Summary

The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.

Clinical Trial Description

Research Question:

Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?

Primary Objectives:

1. To improve the Framingham Risk Score and 7-year MACE score for renal transplant recipients, which estimate risk for cardiovascular disease.

2. To improve the cardiovascular risk inflammatory biomarker profile.

Hypothesis:

The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score, MACE score, as well as markers of inflammation in kidney transplant recipients because:

1. CNI minimization protocols are widely accepted as a strategy to ameliorate allograft and vascular injury.

2. Chronic allograft injury and vascular disease are known inflammatory conditions.

3. The MPA derivatives possess significant anti-inflammatory properties. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02058875
Study type	Interventional
Source	University of Saskatchewan
Contact
Status	Withdrawn
Phase	Phase 4
Start date	February 2014
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02122198` - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women	N/A
Completed	`NCT02502812` - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects	Phase 1
Recruiting	`NCT04216342` - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers	Phase 1
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT03646656` - Heart Health Buddies: Peer Support to Decrease CVD Risk	N/A
Completed	`NCT02081066` - Identification of CETP as a Marker of Atherosclerosis	N/A
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Recruiting	`NCT03095261` - Incentives in Cardiac Rehabilitation	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Completed	`NCT02711878` - Healing Hearts and Mending Minds in Older Adults Living With HIV	N/A
Completed	`NCT02868710` - Individual Variability to Aerobic Exercise Training	N/A
Recruiting	`NCT02885792` - Coronary Artery Disease in Patients Suffering From Schizophrenia	N/A
Completed	`NCT02272946` - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk	Phase 2
Completed	`NCT02657382` - Mental Stress Ischemia: Biofeedback Study	N/A
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Completed	`NCT02640859` - Investigation of Metabolic Risk in Korean Adults
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Active, not recruiting	`NCT02600338` - Meta-analyses of the Effect of Legumes on Blood Pressure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring — COBACAM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms