Assessment of everolimus in addition to calcineurin inhibitors reduction in maintenance renal transplant recipients (ASCERTAIN) - ASCERTAI

ovartis Pharma Services AG0 sites384 target enrollmentStarted: October 20, 2004Last updated: April 18, 2012

Study Overview

No summary available.

•Male or female patient at least 18 years of age.
•Patient who have undergone a primary or secondary renal transplant at least 6 months previous from a living related or unrelated donor or a cadaveric donor.
•Patient receiving Neoral® with a C2-h level = 400 ng/mL or Prograf® with a C0-h level = 4 ng/mL in combination with or without MPA or AZA plus or minus steroids.
•Patient with renal impairment defined as measured GFR between 30 and 70
•mL/min/1.73m2. (For Sweden: Patients with GFR 60-70 mL/min a documented reduction of t least 10 % in GFR as compared to the best post-transplant GFR is required)
•Patient in whom an allograft biopsy is not contraindicated.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient recipient of multiple organ transplants.
•Patient with protein/creatinine ratio = 150 mg/mmol.
•Patient with an acute rejection episode within the last 3 months.
•Patient with any past or present BK-polyomavirus nephropathy.
•Patient with de novo or recurrent glomerular nephritis.
•Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of
•= 2,500/mm3 or with a hemoglobin value < 8 g/dL.
•Presence of severe hypercholesterolemia (= 350 mg/dL or =9.1 mmol/L) or
•hypertriglyceridemia (= 750 mg/dL or =8.55 mmol/L).
•Patient being currently treated or who has been treated with a mTOR inhibitor.
•Patient who had received an investigational drug within 4 weeks.
•Patient who is human immunodeficiency virus (HIV) positive or who has a current
•severe systemic infection according to the investigator judgment requiring continued
•Present use of any other immunosuppressive drugs than Neoral®/Prograf® , MPA/AZA and steroids.

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