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

• Conditions: Renal transplantation; MedDRA version: M15Classification code 10023438

• Registration Number: EUCTR2004-002267-24-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-29
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

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
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

Exclusion Criteria

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
therapy.
Present use of any other immunosuppressive drugs than Neoral®/Prograf® , MPA/AZA and steroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified