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

ovartis Pharma AG0 sites384 target enrollmentMay 29, 2007

Overview

No summary available.

Registry

who.int

Start Date

May 29, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•NEW TEXT ARISING FROM AMENDMENT III SHOWN IN CAPITAL LETTERS
•Male or female patient at least 18 years of age.
•Patient who have undergone a primary or secondary renal transplant AT LEAST 6 MONTHS PREVIOUSLY 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 \= 5 ng/mL in combination with MPA or AZA plus or minus steroids.
•Patient with renal impairment defined as measured GFR between 30 and 70
•mL/min/1\.73m2\.
•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

•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.