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
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
The change in the Framingham 10-yr age and gender adjusted score for coronary heart disease from baseline to Month 6
Baseline to Month 6
Dr. Ramesh Prasad, MBBS MSc
St. Michael's Hospital, Toronto
Canada: Health Canada