Study Stopped
Slow accrual within enrollment time period: projected accrual goal not achieved.
Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15)
4 other identifiers
interventional
46
1 country
5
Brief Summary
The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the amount of other anti-rejection medications necessary and thereby reduce the long-term side effects caused by the other medications. The researchers also want to learn more about the safety of this treatment and long term health of transplanted pancreases and kidneys.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2013
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
December 7, 2017
CompletedJuly 20, 2021
June 1, 2021
3.5 years
February 11, 2013
October 6, 2017
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): * A score of ≥90 means kidney function is normal. * A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. * Scores between 30 and 59 indicates moderately reduced kidney function. * Scores between 15 and 29 indicate severely reduced kidney function. * Scores below 15 indicate very severe or end stage kidney failure.
Week 52 Post-Transplant
Secondary Outcomes (30)
Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
Week 52 Post-Transplant
Count of Participants by CKD Stage at Wk 52 Post-Transplant
Week 52 Post-Transplant
Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
Week 52 Post-Transplant
Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
Week 52 Post-Transplant
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant
Day 28 through Week 52 Post-Transplant
- +25 more secondary outcomes
Study Arms (2)
Immunosuppression without Belatacept
ACTIVE COMPARATOR* Induction: 5 day course of methylprednisolone or equivalent; * Induction: Anti-thymocyte Globulin (Rabbit); * Maintenance Immunosuppression: Tacrolimus (or generic). The site investigator will identify a starting tacrolimus dose at his or her discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. Tacrolimus dosing will be initiated on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed, then adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter. * Maintenance Immunosuppression: Mycophenolate mofetil (or Myfortic (mycophenolate sodium), or generic).
Immunosuppression Including Belatacept
EXPERIMENTAL* Induction: 5 day course of methylprednisolone or equivalent; * Induction: Anti-thymocyte Globulin (Rabbit); * Maintenance Immunosuppression: Belatacept * Maintenance Immunosuppression: Tacrolimus (or generic)- The site investigator will identify a starting tacrolimus dose at his or her discretion, in order to achieve the target trough levels no later than 5 days post-transplantation. Tacrolimus dosing will be initiated on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed. The dosage will be adjusted to achieve the following therapeutic trough levels: 5-8 ng/ml during the first 24 weeks post-transplant and then 3-5 ng/ml until day 280 (week 40). Subjects may be withdrawn if they meet all the criteria defined below. * Maintenance Immunosuppression: Mycophenolate mofetil (or Myfortic (mycophenolate sodium), or generic).
Interventions
The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).
There may be an opportunity to withdraw tacrolimus at week 40
Mycophenolate mofetil will be administered at a target dose of 1000 mg by mouth twice daily (e.g., BID) beginning on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed (maximum MMF dosing is 2G per day). MMF will be adjusted based on clinical complications (such as neutropenia). Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Eligibility Criteria
You may qualify if:
- Ability to understand and provide written informed consent;
- Candidate for a primary simultaneous kidney and pancreas allograft with random c-peptide \<0.3 ng/mL;
- No known contraindications to study therapy using NULOJIX® (belatacept);
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry;
- Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following study completion;
- No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator;
- Negative crossmatch, actual or virtual, or a Panel Reactive Antibodies (PRA) of 0% on historic and admission sera, as determined by each participating study center;
- A documented negative Tuberculosis (TB) test within the 12 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed.
You may not qualify if:
- Need for multi-organ transplantation other than a kidney and pancreas;
- Recipient of previous organ transplant;
- Epstein-Barr Virus (EBV) sero-negative recipients or recipients whose EBV serostatus is unknown prior to the time of transplantation;
- Individuals infected by the hepatitis B or C viruses or HIV;
- Individuals who have required treatment with systemic prednisone or other immunosuppressive drugs within 1 year prior to transplant;
- Individuals previously treated with NULOJIX® (belatacept);
- Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
- Use of investigational drugs within 4 weeks of enrollment;
- Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;
- Administration of live attenuated vaccine(s) within 8 weeks of enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Clinical Trials in Organ Transplantationcollaborator
- Rho Federal Systems Division, Inc.collaborator
- Bristol-Myers Squibbcollaborator
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California San Francisco Medical Center
San Francisco, California, 94143-0780, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Stock PG, Mannon RB, Armstrong B, Watson N, Ikle D, Robien MA, Morrison Y, Odorico J, Fridell J, Mehta AK, Newell KA. Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial. Am J Transplant. 2020 Jun;20(6):1668-1678. doi: 10.1111/ajt.15817. Epub 2020 Mar 8.
PMID: 32039559RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Newell, MD, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2013
First Posted
February 13, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
July 20, 2021
Results First Posted
December 7, 2017
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- On average, data is available within 24 months after database lock for a trial.
- Access Criteria
- Open access. Study's: * Accession ID is SDY1433, and * Digital Object Identifier (DOI) is : 10.21430/M3CEH2A7ZF
Data is available in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.