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

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
University of Tennessee
Information provided by (Responsible Party):
Rita Alloway, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00363116
First received: August 10, 2006
Last updated: October 24, 2013
Last verified: October 2013
  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:


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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence, timing and severity of fungal infections. [ Designated as safety issue: No ]
  • Incidence, timing and severity of malignancies. [ Designated as safety issue: No ]
  • Hospitalizations. [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: April 1999
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5 Dose Daclizbumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Active Comparator: 2 Dose Daclizaumab
daclizumab 2 mg/kg/dose every 14 days for 2 doses
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Active Comparator: Control
no antibody induction
Drug: Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses

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 B surface antigen positive
  • Investigational drug within 30 days prior to transplant surgery
  • Anti-T cell therapy within 30 days prior to transplant surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 24 Study Locations
Sponsors and Collaborators
University of Cincinnati
Roche Pharma AG
University of Tennessee
Investigators
Principal Investigator: Robert J Stratta, MD University of Tennessee
  More Information

No publications provided

Responsible Party: Rita Alloway, Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00363116     History of Changes
Other Study ID Numbers: ZEN049
Study First Received: August 10, 2006
Last Updated: October 24, 2013
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:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Daclizumab
Pancrelipase
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 19, 2014