New Onset Diabetes After TransplantPhase 4NCT01875224
Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
A Phase 4 study testing Belatacept and Tacrolimus in people with New Onset Diabetes After Transplant and Kidney Transplantation, run by University of Arizona at 1 site in United States.
Trial summary
This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- New Onset Diabetes After Transplant, Kidney Transplantation
- What is being tested?
- Belatacept and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2016
- 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
- Written informed consent must be given by patient.
- Adult patients between age 18 and 65
- Thymoglobulin induction at the time of transplant
- Patient must be Epstein-Barr Virus seropositive
Who cannot join
- Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
- Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
- History of stroke, severe cardiac disease or cardiac failure
Trial locations and contacts
1 site in 1 country.
Bruce Kaplan, MD contact
United States1 site
University of Arizona
Tucson, Arizona, 85724
Rochelle Byrne, RN, 520-626-9603, rbyrne@deptofmed.arizona.edu
Bruce Kaplan, MD
About this study
Official title: Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression
This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.
- Being tested
- Belatacept, Tacrolimus
- Keywords
- kidney transplant, diabetes after transplant, belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called Nulojix
TacrolimusDrug
Also called Prograf
Standard administration of tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| Belatacept and CellCept | Experimental | Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily. Receives: Drug: Belatacept |
| Tacrolimus and CellCept | Active comparator | Tacrolimus and CellCept taken twice daily based on patient response. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased insulin sensitivity
Increase in insulin sensitivity (HOMA-S) as calculated below:
FIRI = fasting plasma insulin level
FPG = fasting plasma glucose level
HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI * FPG)
Measured: 12 months
Decreased insulin resistance
Decreased insulin resistance (HOMA-IR) as measured below:
FIRI = fasting plasma insulin level
FPG = fasting plasma glucose level
HOMA IR (insulin resistance) is calculated as (FIRI * FPG) / 22.5
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Onset Diabetes After TransplantStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Bruce Kaplan, University of Arizona
- Investigators
- Bruce Kaplan, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875224
- Sponsor's protocol ID
- IM103-303
- Status last verified
- Jun 2013
- First submitted
- 29 May 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression
- ClinicalTrials.gov ID
- NCT01875224
- Acronym / sponsor ID
- IM103-303
- Keywords
- kidney transplant, diabetes after transplant, belatacept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Jun 2013 (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 study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belatacept and CellCept | Experimental | Drug: BelataceptBelatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily. |
| Tacrolimus and CellCept | Active comparator | Drug: TacrolimusTacrolimus and CellCept taken twice daily based on patient response. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be given by patient.
- Adult patients between age 18 and 65
- Thymoglobulin induction at the time of transplant
- Patient must be Epstein-Barr Virus seropositive
Key exclusion criteria (3 listed)
- Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
- Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
- History of stroke, severe cardiac disease or cardiac failure
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 |
|---|---|---|
| BelataceptAlso: Nulojix | Drug | Belatacept and CellCept |
| TacrolimusAlso: PrografStandard administration of tacrolimus | Drug | Tacrolimus and CellCept |
Primary outcome
Increased insulin sensitivity
Time frame: 12 months
Increase in insulin sensitivity (HOMA-S) as calculated below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI * FPG)
Decreased insulin resistance
Time frame: 12 months
Decreased insulin resistance (HOMA-IR) as measured below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA IR (insulin resistance) is calculated as (FIRI * FPG) / 22.5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
Bruce Kaplan, MD contact
Bruce Kaplan, MD principal investigator
University of Arizona
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 Belatacept and Tacrolimus in people with New Onset Diabetes After Transplant and Kidney Transplantation, run by University of Arizona 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruce Kaplan, MD (520-626-6371), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased insulin sensitivity (time frame: 12 months). The study lists 2 primary outcomes in all. 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 11 Jun 2013.