Delayed Graft FunctionEarly Phase 1NCT02134288
Belatacept for Renal Transplant Recipients With Delayed Graft Function
A Early Phase 1 study testing Belatacept and Everolimus in people with Delayed Graft Function, run by Ohio State University at 1 site in United States.
Trial summary
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- Belatacept and Everolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 18 Jan 2019
- Phase
- Early Phase 1
- 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
- Signed Written Informed Consent
- Deceased donor renal transplant recipient
- Men and women, aged 18-60 years of age
Who cannot join
- Seronegative or unknown EBV serostatus
- Patients unwilling or incapable of providing informed consent.
- Patients with active tuberculosis or positive TB test without evidence of infection treatment.
- Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
- Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
- Inadequate vein access to receive monthly IV infusions
Show all 12Show fewer
- Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
- Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
- Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State Universtiy Wexner Medical Center
Columbus, Ohio, 43212
About this study
Official title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
Read the detailed description
Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).
- Conditions
- Delayed Graft Function
- Being tested
- Belatacept, Everolimus
- Keywords
- Dialysis, Kidney Transplant, immunosuppressive therapy, Delayed Graft Function, Belatacept
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called NULOJIX
EverolimusDrug
Also called zortress
| Study group | Role | What they receive |
|---|---|---|
| Belatacept | Active comparator | Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study. Receives: Drug: Belatacept |
| Everolimus | Active comparator | Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3. Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recover from Delayed Graft Function
For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).
Measured: 2 weeks
Secondary outcomes (12)
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Measured: Assessed at 3, 6, 12 months
Hospital length of stay (days) from date of transplant to discharge
by monitoring patient while inpatient
Measured: up to 7 days
Number of dialysis treatments
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Number of biopsies
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Measured: Assessed at 3, 6, 12 months
Biopsy proven acute rejection events
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Patient and graft survival
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Number of hospital readmissions
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Detection of DSA (Luminex)
by blood draw
Measured: Assessed at 3, 6, 12 months
Incidence and type of infection
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Measured or estimated creatinine clearance.
by blood draw
Measured: Assessed at 3, 6, 12 months
Banff score of rejection episodes and immune suppression treatment/management of rejection
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured: Assessed at 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startApr 2014
- Primary completion11 Dec 2018
- Study completion18 Jan 2019
Why it stopped: Drug unavailability due to a manufacturing transition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Jon Von Visger, M.D./Ph.D., Principal investigator, OSU Wexner Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134288
- Sponsor's protocol ID
- IM103-336
- Other IDs
- 2013H0312
- Status last verified
- Sep 2021
- First submitted
- 21 Apr 2014
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
- ClinicalTrials.gov ID
- NCT02134288
- Acronym / sponsor ID
- IM103-336
- Conditions
- Delayed Graft Function
- Keywords
- Dialysis, Kidney Transplant, immunosuppressive therapy, Delayed Graft Function, Belatacept
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug unavailability due to a manufacturing transition.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2014 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 9 May 2014 (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.
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
Detailed description
Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belatacept | Active comparator | Drug: BelataceptBelatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study. |
| Everolimus | Active comparator | Drug: EverolimusEverolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed Written Informed Consent
- Deceased donor renal transplant recipient
- Men and women, aged 18-60 years of age
Key exclusion criteria (12 listed)
- Seronegative or unknown EBV serostatus
- Patients unwilling or incapable of providing informed consent.
- Patients with active tuberculosis or positive TB test without evidence of infection treatment.
- Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
- Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
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 |
| EverolimusAlso: zortress | Drug | Everolimus |
Primary outcome
Time to recover from Delayed Graft Function
Time frame: 2 weeks
For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).
12 secondary outcomes
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Time frame: Assessed at 3, 6, 12 months
Hospital length of stay (days) from date of transplant to discharge
Time frame: up to 7 days
Number of dialysis treatments
Time frame: Assessed at 3, 6, 12 months
Number of biopsies
Time frame: Assessed at 3, 6, 12 months
Biopsy proven acute rejection events
Time frame: Assessed at 3, 6, 12 months
Patient and graft survival
Time frame: Assessed at 3, 6, 12 months
Number of hospital readmissions
Time frame: Assessed at 3, 6, 12 months
Detection of DSA (Luminex)
Time frame: Assessed at 3, 6, 12 months
Incidence and type of infection
Time frame: Assessed at 3, 6, 12 months
Measured or estimated creatinine clearance.
Time frame: Assessed at 3, 6, 12 months
Banff score of rejection episodes and immune suppression treatment/management of rejection
Time frame: Assessed at 3, 6, 12 months
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
Time frame: Assessed at 3, 6, 12 months
Results and safety
The study was stopped early (reason given: Drug unavailability due to a manufacturing transition.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Delayed Graft Function
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Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
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ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
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Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
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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.
Jon Von Visger, M.D./Ph.D. principal investigator
OSU Wexner Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Belatacept and Everolimus in people with Delayed Graft Function, run by Ohio State 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 3 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: stopped early, as of the sponsor's last update on 23 Sep 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Drug unavailability due to a manufacturing transition.). 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 recover from Delayed Graft Function (time frame: 2 weeks). 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 23 Sep 2021.