DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: RATG/Rituxan (Drug); RATG/Velcade (Drug); RATG/Rituxan/Velcade (Drug); Rabbit Antithymocyte Globulin (RATG) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
E. Steve Woodle, MD, Principal Investigator, Affiliation: University of Cincinnati

Summary

The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.

Clinical Details

Official title: Targeted Therapy for High Immunologic Risk Renal Transplant Recipients: A Prospective, Randomized, Open-Label Pilot Study of B-Cell Depleting Therapy in Combination With Anti-Thymocyte Globulin [Rabbit] (Thymoglobulin®, Genzyme), Tacrolimus (Prograf®, Astellas), Mycophenolate Mofetil (CellCept®, Roche) and Corticosteroid Minimization

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Incidence of acute rejection (Banff '97) or antibody mediated rejection by Banff criteria at 6 months.

Secondary outcome:

Rejection incidence and severity by Banff '97 Criteria (updated 2005)

Rejection incidence and severity by treatment and Banff grade

Patient and allograft survival at 6 and 12 months

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

- Patient has been fully informed and has signed IRB approved informed consent and is

willing and able to follow study procedures

- Patient is considered at high risk for acute rejection by predefined criteria in the

detailed IRB approved protocol

- Women of childbearing potential must use two reliable forms of contraception

Locations and Contacts

The Christ Hospital, Cincinnati, Ohio 45202, United States

The University Hospital, Cincinnati, Ohio 45219, United States

Additional Information

Starting date: September 2008
Last updated: August 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017