CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
mycophenolate mofetil (CellCept)drug
Likely dose
mycophenolate mofetil (CellCept) 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00446459
NCT00446459Phase 2Completed
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The Highly Sensitized Patients: Effects of Mycophenolate Mofetil (MMF) On Anti-Human Leukocyte Antigen (HLA) Antibody Levels In Patients Awaiting Cadaveric Renal Transplant

University of Washington·interventional·Posted Mar 12, 2007·Updated Apr 15, 2010

In Brief

A Phase 2 clinical trial evaluating mycophenolate mofetil (CellCept) for Kidney Failure, Chronic and 3 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This is a 12-month, phase II, prospective, open label study, to evaluate the effect of mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of Reactive Antibody (PRA) levels. On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement Organization (OPO) increases the waiting time from 3 to 6 years. Spontaneous decreases in the PRA rarely occur and is associated with a decreased chance for transplantation and a decreased rate of survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal
CountriesUnited States
CollaboratorsHoffmann-La Roche

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2007
Enrollment StartApr 1, 2006
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.3 years ago

Interventions

mycophenolate mofetil (CellCept)drug

500mg - 1,000mg, taken PO, twice daily.