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

Renal Transplantation Clinical Trial

Official title:

Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170846
• Other study ID #: CRAD001A2413
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: January 15, 2015
• Start date: February 2005
• Est. completion date: October 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Everolimus (RAD001)

• Calcineurin Inhibitors (CNI)

• Mycophenolate acid (MPA)/Azathioprine (AZA)

• Steroids

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Function Assessed by Measured GFR (mGFR)	The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.	24 months	No
Secondary	Number of Participants With Safety Parameters	The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.	24 months	No