NephrotoxicityPhase 4NCT02103855
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
A Phase 4 study testing Belatacept in people with Nephrotoxicity, run by Indiana University at 1 site in United States.
Trial summary
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephrotoxicity
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreas transplant alone recipients
- EBV IgG positive
- Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
- Maintained on a regimen of tacrolimus, sirolimus, mycophenolate
Who cannot join
- EBV IgG negative
- Not maintained on an immunosuppression regimen that contains tacrolimus
- Unable or unwilling to give informed consent
- Active infection
- History of malignancy post transplant
- Glomerular filtration rate < 15 mL/min
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health, University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.
Read the detailed description
Nephrotoxicity is a major complication of current immunosuppression regimens used in transplantation. Pancreas transplantation has been increasedly performed to manage labile diabetes mellitus during the last few decades and survival rates of pancreatic grafts are improving. One of the challenges that is faced following pancreas transplantation alone are pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors for decline in kidney function and progression to end-stage renal disease. The objective of this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin belatacept, which is not a CNI.
The hypothesis is by switching the pancreas transplant subject with documented CNI kidney toxicity to belatacept will slow the progression of chronic kidney disease.
- Conditions
- Nephrotoxicity
- Being tested
- Belatacept
- Keywords
- pancreas transplantation, immunosuppression, belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called Nulojix
| Study group | Role | What they receive |
|---|---|---|
| belatacept | Experimental | Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. Receives: Drug: Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)
Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept
Measured: Baseline and 1 year
Serum Creatinine at Year 1
Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.
Measured: 1 year
Secondary outcomes (3)
Number of Participants With Pancreas Transplant Rejection
Pancreas Rejection as measured by serum amylase, serum lipase.
Measured: 1 year
Change From Baseline Serum Hemoglobin A1c
Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.
Measured: Baseline and 1 year
Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.
Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 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 NephrotoxicityStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asif Sharfuddin, Indiana University
- Investigators
- Asif Sharfuddin, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103855
- Sponsor's protocol ID
- BMS 103-337
- Status last verified
- Aug 2017
- First submitted
- 1 Apr 2014
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients
- ClinicalTrials.gov ID
- NCT02103855
- Acronym / sponsor ID
- BMS 103-337
- Conditions
- Nephrotoxicity
- Keywords
- pancreas transplantation, immunosuppression, belatacept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.
Detailed description
Nephrotoxicity is a major complication of current immunosuppression regimens used in transplantation. Pancreas transplantation has been increasedly performed to manage labile diabetes mellitus during the last few decades and survival rates of pancreatic grafts are improving. One of the challenges that is faced following pancreas transplantation alone are pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors for decline in kidney function and progression to end-stage renal disease. The objective of this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin belatacept, which is not a CNI.
The hypothesis is by switching the pancreas transplant subject with documented CNI kidney toxicity to belatacept will slow the progression of chronic kidney disease.
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: BelataceptBelatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pancreas transplant alone recipients
- EBV IgG positive
- Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
- Maintained on a regimen of tacrolimus, sirolimus, mycophenolate
Key exclusion criteria (6 listed)
- EBV IgG negative
- Not maintained on an immunosuppression regimen that contains tacrolimus
- Unable or unwilling to give informed consent
- Active infection
- History of malignancy post transplant
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 |
Primary outcome
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and 1 year
Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept
Serum Creatinine at Year 1
Time frame: 1 year
Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.
3 secondary outcomes
Number of Participants With Pancreas Transplant Rejection
Time frame: 1 year
Change From Baseline Serum Hemoglobin A1c
Time frame: Baseline and 1 year
Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nephrotoxicity
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
Active, not recruitingPhase 3
Cisplatin Disposition and Kidney Injury
Nephrotoxicity
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Not yet recruitingObservational study
Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-C
Nephrotoxicity, Bacterial Infections
Not yet recruitingPhase 3
Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
Nephrotoxicity
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.
Asif Sharfuddin, MD principal investigator
Indiana University
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 Nephrotoxicity, run by Indiana 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 4 inclusion and 6 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 28 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 28 Aug 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 From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) (time frame: Baseline and 1 year). 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 28 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.