MedTrace Logo

Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

NCT00275509 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-01-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

Conditions

  • Kidney Failure, Chronic

Interventions

DRUG

Thymoglobulin

DRUG

Daclizumab

OTHER

Plasmapheresis

Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered

DRUG

Mycophenolate mofetil

2 gm/day. Standard of care

DRUG

Tacrolimus

To achieve serum level of 8-10 ng/ml.

DRUG

Dexamethasone

100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses

DRUG

Prednisone

Taper over three months to 5 mg daily

DRUG

Cytogam

Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered

Sponsors & Collaborators

Principal Investigators

  • Robert A Montgomery, M.D., Ph.D. · Johns Hopkins University , SOM

  • Christopher E Simpkins, M.D. · Johns Hopkins University, SOM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00275509 on ClinicalTrials.gov