NCT01213394

Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients

A 6-month, Prospective, Open-label, Randomized, Controlled, Pilot Study Evaluating the Efficacy, Safety and Toxicity of an Optimized Immunosuppressive Regimen of CellCept (Mycophenolate Mofetil, MMF) and Reduced Doses of Both Calcineurin-inhibitors and Prednisone in Renal Transplant Recipients With an Increased 10-year Coronary Heart Disease Risk

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ramesh Prasad · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if adding or increasing the dose of CellCept while lowering the dose of tacrolimus (Prograf or Advagraf) or cyclosporine (Neoral), and/or steroids can reduce the likelihood of developing coronary heart disease in the next 10 years. The investigators will calculate the change in risk of developing coronary heart disease using the Framingham score. The Framingham score is a mathematical equation that includes the following information: Age, Gender, Diabetes status, Smoking status, Lipids, Blood Pressure. The Framingham score estimates how likely it is that someone will develop coronary heart disease over the next 10 years.

Detailed description

Kidney transplant recipients are required to take medications called immunosuppressants to lower their immune systems to help protect the donated kidney. The medications have improved over the years and as a result the donated kidneys are generally working longer. This allows the Transplant Team to focus more on the long term complications of kidney transplantation such as cardiovascular disease. There have been few prospective (looking forward) research studies looking at kidney transplant recipient cardiovascular risk factors after transplant. We know that immunosuppressive medications have a number of serious side effects that can increase cardiovascular disease risk factors such as high blood pressure, high lipids (fats in the blood), and high blood sugar. Medications such as tacrolimus, cyclosporine and prednisone work well to protect the donated kidney but are also known to increase the risk of developing or worsening cardiovascular disease. CellCept is another type of immunosuppressive agent. CellCept is not associated as much with the risk of developing cardiovascular disease. This is a pilot study being done to collect information about cardiovascular risk factors in kidney transplant recipients and to see if adjusting the immunosuppressive medications can help to lower the overall risk for developing heart disease in the future. This research study plans to enroll 45 participants from 2 different transplant centres in Canada: St. Michael's Hospital in Toronto and St. Paul's Hospital in Saskatoon. The study duration is approximately 7 months per participant. The study will be looking for participants who are 30 years of age or older and who are at least 6 months after the transplant operation.

Conditions

• Kidney Transplantation
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	mycophenolate mofetil	Introduction of CellCept or increase in the dose of CellCept to a maximum of 2 g/day. In patients not already receiving CellCept, azathioprine (AZA), enteric-coated mycophenolate sodium (EC-MPS) or sirolimus (SRL) will be discontinued and replaced by CellCept in divided doses to a maximum of 2 g/day. CNI doses will be reduced to conform to the target trough levels in the low-dose CNI arms of the ELITE-Symphony study +/- steroid dose reduction. Any CNI dose change will require measurement of CNI trough levels at 7 days post dose change +/- 3 days. Target CNI trough levels in the Symphony study: * Low-dose CsA: Initial oral dose of 1-2 mg/kg bid, to achieve a target trough level of 50-100 ng/mL. * Low-dose TAC: Initial oral dose of 0.1 mg/kg/day divided into two doses\* with a target trough level of 3-7 ng/mL (\*Advagraf may also be used at a dose of 0.1 mg/kg once daily with a target trough level of 3-7 ng/mL)
OTHER	standard immunosuppression	Current immunosuppressive therapy will be maintained throughout the study unless a change is required for safety reasons.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2010-10-04
• Last updated: 2012-04-19

Locations

1 site across 1 country: Canada