Phase 4
N=394
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
Renal Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00170846 ↗Enrolled (actual)
394
Serious AEs
51.3%
Results posted
May 2011
Primary outcome: Primary: Renal Function Assessed by Measured GFR (mGFR) — 46.02; 48.00; 46.60 mL/min/1.73m^2 — p=0.6332
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (RAD001) (Drug); Calcineurin Inhibitors (CNI) (Drug); Mycophenolate acid (MPA)/Azathioprine (AZA) (Drug); Steroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function Assessed by Measured GFR (mGFR) |
46.02; 48.00; 46.60 | 0.6332 |
| SECONDARY Number of Participants With Safety Parameters |
6; 13; 9; 117; 114; 135 | — |
Summary
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.
Eligibility Criteria
Inclusion Criteria
- Male or female patient at least 18 years of age.
- Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
- Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
- The immunosuppressive regimen must remain unchanged within the last 3 months.
- Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m^2 by Cockcroft-Gault formula.
Exclusion Criteria
- Patient who is recipient of multiple organ transplants.
- Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
- Patient with a treated 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.
Other protocol defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00170846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.