Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant RecipientsPhase 4NCT00363116
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
A Phase 4 study testing Daclizumab in people with Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients, run by University of Cincinnati at 24 sites in 2 countries.
Trial summary
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
- What is being tested?
- Daclizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Apr 1999to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Emory University
Atlanta, Georgia, 30322
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolina Medical Center
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60208
University of Chicago
Chicago, Illinois, 60637
University of Maryland
College Park, Maryland, 20742
Ohio State University
Columbus, Ohio, 43210
University of California - Davis
Davis, California, 95616
Duke University
Durham, North Carolina, 27708
University of Texas - Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Cornell University
Ithaca, New York, 14853
University of California - Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53705
University of Tennessee
Memphis, Tennessee, 38163
University of Miami
Miami, Florida, 33124
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Oregon Health Science University
Portland, Oregon, 97239
Medical College of Virginia
Richmond, Virginia, 23298
University of Washington
Seattle, Washington, 98195
Baylor University
Waco, Texas, 76798
Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
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
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
Read the 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.
- Being tested
- Daclizumab
- Keywords
- Kidney transplant, Pancreas transplant, Daclizumab, Tacrolimus, Mycophenolate mofetil, Steroids, Immunosuppression, Acute allograft rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
daclizumab 1 mg/kg/dose every 14 days for 5 doses
| Study group | Role | What they receive |
|---|---|---|
| 5 Dose Daclizbumab | Active comparator | daclizumab 1 mg/kg/dose every 14 days for 5 doses Receives: Drug: Daclizumab |
| 2 Dose Daclizaumab | Active comparator | daclizumab 2 mg/kg/dose every 14 days for 2 doses Receives: Drug: Daclizumab |
| Control | Active comparator | no antibody induction Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startApr 1999
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, University of Tennessee
- Responsible party
- Principal investigator, Rita Alloway, University of Cincinnati
- Investigators
- Robert J Stratta, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363116
- Sponsor's protocol ID
- ZEN049
- Status last verified
- Oct 2013
- First submitted
- 10 Aug 2006
- Last updated
- 25 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00363116
- Acronym / sponsor ID
- ZEN049
- Keywords
- Kidney transplant, Pancreas transplant, Daclizumab, Tacrolimus, Mycophenolate mofetil, Steroids, Immunosuppression, Acute allograft rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Roche Pharma AG, University of Tennessee
- Study start
- Apr 1999
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 Dose Daclizbumab | Active comparator | Drug: Daclizumabdaclizumab 1 mg/kg/dose every 14 days for 5 doses |
| 2 Dose Daclizaumab | Active comparator | Drug: Daclizumabdaclizumab 2 mg/kg/dose every 14 days for 2 doses |
| Control | Active comparator | Drug: Daclizumabno antibody induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclizumabdaclizumab 1 mg/kg/dose every 14 days for 5 doses | Drug | 2 Dose Daclizaumab, 5 Dose Daclizbumab, Control |
Primary outcome
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.
3 secondary outcomes
Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Stratta, MD principal investigator
University of Tennessee
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daclizumab in people with Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients, run by University of Cincinnati at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.