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ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

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Novartis

Status and phase

Completed
Phase 4

Conditions

Renal Transplantation

Treatments

Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
Drug: Calcineurin Inhibitors (CNI)
Drug: Everolimus (RAD001)
Drug: Steroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170846
CRAD001A2413

Details and patient eligibility

About

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.

Enrollment

394 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

394 participants in 3 patient groups

Group A: No RAD
Active Comparator group
Description:
Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
Treatment:
Drug: Calcineurin Inhibitors (CNI)
Drug: Steroids
Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
Group B : CNI Withdrawal
Experimental group
Description:
Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.
Treatment:
Drug: Everolimus (RAD001)
Drug: Steroids
Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
Group C: CNI Reduction
Experimental group
Description:
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
Treatment:
Drug: Calcineurin Inhibitors (CNI)
Drug: Everolimus (RAD001)
Drug: Steroids
Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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