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Safety and Efficacy of a Steroid-free, Calcineurin Inhibitor-free, Belatacept-based Immunosuppressive Regimen

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation; Transplantation

Intervention: Anti-thymocyte Globulin (Rabbit) (Biological); Belatacept (Biological); Methylprednisolone (Drug); Basiliximab (Biological); Mycophenolate Mofetil (Drug); Tacrolimus (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Kenneth Newell, MD, PhD, Principal Investigator, Affiliation: Emory University
Roslyn B. Mannon, M.D., Study Chair, Affiliation: University of Alabama at Birmingham

Summary

Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who get a kidney transplant must take these anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work. Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. There would be a benefit to finding new anti-rejection medications that work just as well, but don't damage the kidney. The purpose of this study is to find out if NULOJIX® (belatacept), will minimize serious long term side effects seen with anti-rejection medications while still protecting your new kidney from damage. The researchers also want to learn more about the safety of this treatment and long term health of your transplanted kidney.

Clinical Details

Official title: Steroid and Tacrolimus Avoidance Using NULOJIX« (Belatacept) in Renal Transplantation (CTOT-16)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean estimated glomerular filtration rate (eGFR) calculated for each treatment group using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)

Secondary outcome:

The incidence of clinically suspected and biopsy proven acute rejection within the first 52 weeks as defined by histologic evidence of rejection and graft dysfunction.

Proportion of subjects with estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)

Change in chronic kidney disease (CKD) stages from baseline.

Proportion of subjects with defined chronic kidney disease (CKD) stage 4 or 5.

Mean calculated estimated glomerular filtration rate (eGFR) using modification of diet in renal disease (MDRD) 4 variable model.

The slope of estimated glomerular filtration Rate (eGFR) by chronic kidney disease epidemiology collaboration equation (CKD-EPI) over time based on serum creatinine collected at all visits indicated on the schedule of events

The incidence of delayed graft function

The incidence of acute cellular rejection grade equal to or > than IA, by the Banff 2007 criteria, within the first 52 weeks.

The severity of first and highest grade of acute cellular rejection within the first 52 weeks

The incidence of antibody mediated rejection

The type of treatment of rejection.

The prevalence of de novo anti-donor histocompatibility antigen (HLA) antibodies

The incidence of new onset diabetes after transplant (NODAT) or impaired fasting glucose (IFG)based on criteria specified by the ADA and WHO

The incidence of treated diabetes between day 14 and week 52

Hemoglobin A1c (HbA1c) measurements

Standardized blood pressure measurement and use of anti-hypertensive medications

Fasting lipid profile (total cholesterol, non-high density lipoprotein cholesterol, low-density lipoprotein, high density lipoprotein, and triglyceride) and use lipid lowering medications

Total daily prescribed pill count

The incidence of death or graft loss.

The incidence of rejection.

The incidence of all adverse events (AEs) and serious adverse events (SAEs)

The incidence of infections requiring hospitalization, or systemic therapy

The incidence of BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) viremia (local center monitoring)

The incidence of Epstein Barr Virus (EBV) infection as reported on the case report form

The incidence fever > 39 degrees and blood pressure < 90mm Hg within 24 hours of onset of transplant procedure

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or Female, 18-65 years of age at the time of enrollment; 2. Ability to understand and provide written informed consent; 3. Candidate for primary renal allograft from either a living or deceased donor; 4. No known contraindications to study therapy using NULOJIX® (belatacept); 5. Female participants of childbearing potential must have a negative pregnancy test upon study entry; 6. Participants with reproductive potential must agree to use an appropriate method(s) of birth control as outlined in the CellCept® , Myfortic® or generic package labeling during participation in the study and for 4 months following completion of the study; 7. No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator; 8. Negative crossmatch or a PRA of 0% on historic and current sera, as determined by each participating study center. 9. A documented negative TB test within the 6 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. Exclusion Criteria: 1. Need for multi-organ transplant 2. Recipient of previous organ transplant 3. Epstein Barr Virus (EBV) sero-negative (or unknown) recipients 4. Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus (HIV) 5. Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant 6. Individuals undergoing transplant using organs from extended criteria donor (ECD) or donation after cardiac death (DCD) donors 7. Histocompatibility antigen (HLA) identical living donors 8. Individuals at significant risk of early recurrence of the primary renal disease including focal segmental glomerulosclerosis (FSGS) and membranoproliferative glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function 9. Known history of thrombotic events or risk factors; including any of the following: 1. Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated anticardiolipin antibody, heparin induced thrombocytopenia 2. A family history of a heritable thrombotic condition, 3. Recurrent DVT or PE, 4. Unexplained stillborn infant or recurrent spontaneous abortion or other congenital or acquired thrombotic disorder At the discretion of the investigator, a history of thrombosis of a dialysis access graft, fistula, or indwelling catheter/device may not be considered an exclusion criterion 10. Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 11. Use of investigational drugs within 4 weeks of enrollment 12. Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components 13. Administration of live attenuated vaccine(s) within 8 weeks of enrollment

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of California, San Francisco, San Francisco, California 94143, United States

Emory University, Atlanta, Georgia 30322, United States

Additional Information

National Institute of Allergy and Infectious Diseases (NIAID)

Clinical Trials in Organ Transplantation (CTOT)

Starting date: July 2013
Last updated: April 29, 2015

Page last updated: August 23, 2015

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