A Trial of Two Daclizumab Dosing Strategies Vs. No Induction Treatment With Tacrolimus, MMF, & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

This study has been completed.

First Received on August 10, 2006. No Changes Posted

Sponsor:	University of Cincinnati
Collaborators:	Hoffmann-La Roche University of Tennessee
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00363116

Purpose

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

Condition	Intervention	Phase
Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients	Drug: Daclizumab	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Pancreas Transplantation

Drug Information available for: Pancrelipase Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil Daclizumab

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.

Secondary Outcome Measures:

Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.

Estimated Enrollment:

240

Detailed Description:

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Simultaneous kidney/pancreas transplant recipients
Insulin dependent Type 1 or 2 diabetes pretransplant
Recipient age 18-65 years
Donor age 5-65 years
Women must have negative serum pregnancy test and practice birth control for study duration
Negative T-cell crossmatch
Parent (or guardian) is able to understand the consent form and give written informed consent

Exclusion Criteria:

Prior treatment with daclizumab
Known sensitivity or contraindication to tacrolimus, MMF, or steroids
Patient with significant or active infection
Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
Patients whose life expectancy is severely limited by diseases other than renal disease
Ongoing substance abuse, drug or alcohol
Major ongoing psychiatric illness or recent history of noncompliance
Insufficient cardiovascular reserve
Malignancy within last 5 years, excluding nonmelanoma skin cancers
Serologic evidence of infection with HIV or Hepatitis BsAg positive
Investigational drug within 30 days prior to transplant surgery
Anti-T cell therapy within 30 days prior to transplant surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363116

Show 24 Study Locations

Sponsors and Collaborators

University of Cincinnati

Hoffmann-La Roche

University of Tennessee

Investigators

Principal Investigator:

Robert J Stratta, MD

University of Tennessee

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00363116 History of Changes
Other Study ID Numbers:	ZEN049
Study First Received:	August 10, 2006
Last Updated:	August 10, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

Kidney transplant
Pancreas transplant
Daclizumab
Tacrolimus

Mycophenolate mofetil
Steroids
Immunosuppression
Acute allograft rejection

Additional relevant MeSH terms:

Pancrelipase
Mycophenolate mofetil
Tacrolimus
Daclizumab
Gastrointestinal Agents

Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2012