CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 394 enrolled
Drug / intervention
Everolimus (RAD001) +3 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓At least 18 years old
  • ✓Primary or secondary renal transplant performed 12–96 months (1–8 years) before enrollment
  • ✓Receiving either cyclosporine microemulsion (C2-h ≥400 ng/mL) or tacrolimus (C0-h ≥4 ng/mL), with or without mycophenolic acid, azathioprine, and/or steroids
  • ✓Immunosuppressive regimen unchanged in the last 3 months
Key exclusion· 5
  • ✕Multiple organ transplant recipient
  • ✕Protein-to-creatinine ratio ≥150 mg/mmol
  • ✕Acute rejection episode treated within the last 3 months
  • ✕History of BK-polyomavirus nephropathy (past or present)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00170846
NCT00170846Phase 4Completed
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Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated Jan 27, 2015

In Brief

A Phase 4 clinical trial evaluating Everolimus (RAD001), Calcineurin Inhibitors (CNI), and 2 other interventions for Renal Transplantation. Completed, enrolled 394 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
CountriesSwitzerland
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartFeb 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago

Interventions

Everolimus (RAD001)drug

Calcineurin Inhibitors (CNI)drug

Mycophenolate acid (MPA)/Azathioprine (AZA)drug

Steroidsdrug