Clareo Health | Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;
Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;
Graft must be functional (producing greater than or equal to 100 ml of urine within 24 hours after transplantation) at time of randomization.
You may not be if
Donor organ with a cold ischemic time \> 30 hours;
Males or females who produce less than 100 ml of urine in the first 24 hours post-transplantation;
Males or females who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
Males or females with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
Males or females who have any surgical or any medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might alter the absorption, distribution, metabolism and/or excretion of study medication.
