CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Calcineurin inhibitor withdrawaldrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Received renal transplant with Campath-1H induction
  • ✓At least 2 months of calcineurin inhibitor therapy (tacrolimus or cyclosporine)
  • ✓Concurrent mycophenolate (CellCept) therapy
  • ✓Concurrent prednisone therapy
Key exclusion· 4
  • ✕HLA-identical living-donor renal transplant recipients
  • ✕Panel reactive antibody (PRA) >20% within 30 days of transplant
  • ✕Glomerular filtration rate (GFR) <40 ml/min
  • ✕Multi-organ transplant recipients

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

Search/NCT00214201
NCT00214201N/ACompleted
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Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

University of Wisconsin, Madison·interventional·Posted Sep 21, 2005·Updated Oct 3, 2012

In Brief

A clinical study evaluating Calcineurin inhibitor withdrawal for Primary Renal Transplant. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Renal Transplant
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartMay 1, 2003
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.8 years ago

Interventions

Calcineurin inhibitor withdrawaldrug

stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy