CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
CMVIGdrug
Likely dose
CMVIG 400mg/kgfrom 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/NCT00784979
NCT00784979Phase 4Completed

Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation

Tampa General Hospital·interventional·Posted Nov 5, 2008·Updated Jun 29, 2015

In Brief

A Phase 4 clinical trial evaluating CMVIG for End Stage Renal Disease. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases: 1. Immunological Testing 2. Transplant Nephrectomy 3. Pharmacologic Therapy 4. Plasmapheresis 5. Transplant

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCSL Behring

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2008
Enrollment StartJan 1, 2002
Primary CompletionDec 1, 2010
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 17.7 years ago

Interventions

CMVIGdrug

400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks