Clinical trial comparing immunosuppresion and the effects on kidney function in Lung transplantation (REVOLUTION trial)

Envarsus ® is a new drug to prevent organ rejection in solid organ transplantation.

Lung transplantation is a life-saving option in patients with severe shortness of breath due to their lung disease. The introduction of drugs preventing rejection of the lungs has prolonged lives and quality of live. The most frequently used drug is tacrolimus a calcineurin inhibitor in combination with prednisolone and a cell cycle inhibitor. These drugs have shown to reduce both acute and chronic rejection. However, a drawback to the administration of tacrolimus is its toxicity due to high peak serum levels in lung transplant recipients. Common side effects are renal impairment, hypertension, and new onset of diabetes. The International Society of Heart and Lung Transplantation (ISHLT) report incidence of sever renal impairment, dialysis or renal transplant of 11.4% after 2 years and 22,3% 5 years post lung transplantation. In lung transplant recipients the incidence of hypertension and diabetes is 23% and 19.8%-23% after 1 year and 50% and 34.4%-40% after 5 years. All these factors affect quality of live post lung transplantation.

In the REVOLUTION study Envarsus ® will be compared to Prograft ® and the effect on chronic kidney disease. Where administration of Envarsus ® will lead to less chronic kidney disease.

At the end of this study, it will be showed that in lung transplant patients treated with Envarsus® there’s less chronic kidney disease, and renal replacement therapy, with improved quality of life.