Completed
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
What is being tested
Daclizumab
Drug
Who is being recruted
From 18 to 65 Years
+19 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 4
Interventional
Study Start: April 1999
Summary
Principal SponsorUniversity of Cincinnati
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 1999
Actual date on which the first participant was enrolled.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.
Official TitleAn 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
Principal SponsorUniversity of Cincinnati
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
298 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
Simultaneous kidney/pancreas transplant recipients
Insulin dependent Type 1 or 2 diabetes pretransplant
Recipient age 18-65 years
Donor age 5-65 years
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12 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active Comparatordaclizumab 2 mg/kg/dose every 14 days for 2 doses
Group II
Active Comparatordaclizumab 1 mg/kg/dose every 14 days for 5 doses
Group III
Active Comparatorno antibody induction
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Suspended
University of California - Davis
Davis, United StatesOpen University of California - Davis in Google MapsSuspended
University of California - Los Angeles
Los Angeles, United StatesSuspended
Washington Hospital
Washington D.C., United StatesSuspended
University of Miami
Miami, United StatesCompleted24 Study Centers