Kidney TransplantationPhase 4NCT02078193
Efficacy of Belatacept in Reducing DSA
A Phase 4 study testing Belatacept in people with Kidney Transplantation, run by East Carolina University at 1 site in United States.
Trial summary
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Belatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.
- Patients with stable renal function. Stable renal function is defined as one serum creatinine (SCr) value that is +/- 10% of the baseline SCr within 3 months of enrollment (eGFR >/= 35 and </= 75 mL/min/1.73m^2).
- Patients who are EBV seropositive
- Males and females, 18-75 years of age;
- Patients currently receiving mycophenolic acid (MPA) (CellCept daily or myfortic daily), cyclosporine or tacrolimus with corticosteroids as part of their immunosuppressive regimen
- Patients willing to be converted to belatacept from cyclosporine or tacrolimus.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment. The test should be performed at baseline visit. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication;
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet, bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed);
- Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit;
- Patients who have received any investigational drug within 4 weeks prior to study entry;
- Patients with HLA identical
- Patients who are Epstein-Barr virus (EBV) seronegative
- Presence of clinically significant infection requiring continued therapy, chronic infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would interfere with the appropriate conduct of the study;
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- Evidence of severe liver disease (incl. abnormal liver profile i.e. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or total bilirubin >/= 3 times ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study;
- Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study;
- Patients with symptoms of significant somatic or mental illness or evidence of drug and/or alcohol abuse;
- Patients receiving > 10 mg/day prednisone dose;
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures to belatacept;
- Patients not making DSA antibodies;
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (local); females of childbearing potential who are unwilling to use effective study-approved contraceptives and who are planning to become pregnant; Sexually active fertile men must use effective birth control if their partners are women of child bearing potential;
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study, including but not limited to visual problems or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific Human Leukocyte Antigen (HLA) Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).
Read the detailed description
The aim of this study is to evaluate patients converted to belatacept in combination with Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their calcineurin inhibitor (CNI) to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.
- Conditions
- Kidney Transplantation
- Being tested
- Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Patients will be converted from their MMF to Belatacept
| Study group | Role | What they receive |
|---|---|---|
| Belatacept | Experimental | Participants will be converted from their current MMF to once a month infusions of Belatacept Receives: Drug: Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Donor Specific Antibodies (DSA)
DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.
Measured: one year
Secondary outcomes (1)
Safety
Incidence of infections
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Bolin, East Carolina University
- Investigators
- Paul Bolin, MD, Principal investigator, East Carolina University, Department Chair of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078193
- Sponsor's protocol ID
- IM103-302
- Status last verified
- Jul 2017
- First submitted
- 3 Mar 2014
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific Human Leukocyte Antigen (HLA) Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02078193
- Acronym / sponsor ID
- IM103-302
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 6 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).
Detailed description
The aim of this study is to evaluate patients converted to belatacept in combination with Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their calcineurin inhibitor (CNI) to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belatacept | Experimental | Drug: BelataceptParticipants will be converted from their current MMF to once a month infusions of Belatacept |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.
- Patients with stable renal function. Stable renal function is defined as one serum creatinine (SCr) value that is +/- 10% of the baseline SCr within 3 months of enrollment (eGFR >/= 35 and </= 75 mL/min/1.73m^2).
- Patients who are EBV seropositive
- Males and females, 18-75 years of age;
- Patients currently receiving mycophenolic acid (MPA) (CellCept daily or myfortic daily), cyclosporine or tacrolimus with corticosteroids as part of their immunosuppressive regimen
Key exclusion criteria (14 listed)
- Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet, bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed);
- Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit;
- Patients who have received any investigational drug within 4 weeks prior to study entry;
- Patients with HLA identical
- Patients who are Epstein-Barr virus (EBV) seronegative
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 |
|---|---|---|
| BelataceptPatients will be converted from their MMF to Belatacept | Drug | Belatacept |
Primary outcome
Change of Donor Specific Antibodies (DSA)
Time frame: one year
DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.
1 secondary outcome
Safety
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Bolin, MD principal investigator
East Carolina University, Department Chair of Internal Medicine
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 in people with Kidney Transplantation, run by East Carolina University 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 8 inclusion and 14 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 1 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Donor Specific Antibodies (DSA) (time frame: one year). 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 1 Aug 2017.