Diabetes MellitusPhase 4NCT00177138
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
A Phase 4 study testing Tacrolimus and Alemtuzumab in people with Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
Trial summary
This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview. Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Tacrolimus and Alemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2006
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
- Recipient age 18-60 years
- Donor age 10-59 years
- Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
- Enteric or bladder drained pancreas transplant.
- -
Who cannot join
- Use of an investigational drug in the last 1-year.
- Positive T or B cell crossmatch.
- WBC<3000 at enrollment
- Platelet count <50,000 at enrollment
- History of malignancy (exclusive of minor skin cancers)
- Inability to give informed consent
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- Systemic infections
- Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).
- Serology negative for EBV pre-transplant.
- No other previous organ transplants other than pancreas and/or kidney. -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota-Fairview
Minneapolis, Minnesota, 55414
About this study
This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.
Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.
Read the detailed description
Secondary objectives of the study are:
- Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
- Compare the incidence of infections between both groups.
Comparison parameters are:
- Pancreas and kidney graft failure
- Patient death
- Clinical and biopsy documented rejection episodes
- Patient dropout (non-compliance with the study protocol)
- Kidney function as assessed by creatinine clearance or biopsy
- Need to change immunosuppression regimen
- Quality-adjusted Life Years
- Conditions
- Diabetes Mellitus
- Being tested
- Tacrolimus, Alemtuzumab
- Keywords
- Campath Study, Pancreas After Kidney Transplantation, Alemtuzumab
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
AlemtuzumabDrug
30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Active comparator | Tacrolimus/MMF/TMG Receives: Drug: Tacrolimus |
| Group 1 | Experimental | Campath/MMF/TMG Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance.
Measured: 2 years
Secondary outcomes (1)
The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2004
- Study completionNov 2006
Why it stopped: The clinical use of Campath for transplant patients was temporarily suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Gruessner, Rainer, MD
- Responsible party
- Sponsor
- Investigators
- Rainer W Gruessner, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177138
- Sponsor's protocol ID
- 0308M51264
- Other IDs
- Berlex Study No. 107.G0001
- Status last verified
- Feb 2013
- First submitted
- 13 Sep 2005
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00177138
- Acronym / sponsor ID
- 0308M51264
- Conditions
- Diabetes Mellitus
- Keywords
- Campath Study, Pancreas After Kidney Transplantation, Alemtuzumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical use of Campath for transplant patients was temporarily suspended.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Bayer, Gruessner, Rainer, MD
- Study start
- Jul 2004
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Sep 2005 (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.
This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.
Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.
Detailed description
Secondary objectives of the study are:
- Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
- Compare the incidence of infections between both groups.
Comparison parameters are:
- Pancreas and kidney graft failure
- Patient death
- Clinical and biopsy documented rejection episodes
- Patient dropout (non-compliance with the study protocol)
- Kidney function as assessed by creatinine clearance or biopsy
- Need to change immunosuppression regimen
- Quality-adjusted Life Years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Drug: TacrolimusTacrolimus/MMF/TMG |
| Group 1 | Experimental | Drug: AlemtuzumabCampath/MMF/TMG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
- Recipient age 18-60 years
- Donor age 10-59 years
- Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
- Enteric or bladder drained pancreas transplant.
Key exclusion criteria (10 listed)
- Use of an investigational drug in the last 1-year.
- Positive T or B cell crossmatch.
- WBC<3000 at enrollment
- Platelet count <50,000 at enrollment
- History of malignancy (exclusive of minor skin cancers)
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 |
|---|---|---|
| TacrolimusStarting POD #1 0.06 mg/kg/day in 2 divided doses; | Drug | Group 2 |
| Alemtuzumab30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year) | Drug | Group 1 |
Primary outcome
Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance.
Time frame: 2 years
1 secondary outcome
The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The clinical use of Campath for transplant patients was temporarily suspended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Rainer W Gruessner, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus and Alemtuzumab in people with Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: The clinical use of Campath for transplant patients was temporarily suspended.). Results are not available in the source record.
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?
Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance. (time frame: 2 years). 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 7 Feb 2013.