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Trial record 1 of 1 for:    IM103-177
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Regimen Optimization Study

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ClinicalTrials.gov Identifier: NCT02137239
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Thymoglobulin Drug: Belatacept Drug: mycophenolate mofetil(MMF) Drug: Corticosteroids Drug: Everolimus(EVL) Drug: Tacrolimus(TAC) Phase 2

Detailed Description:
Calcineurin inhibitor (CNI)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression
Actual Study Start Date : December 31, 2015
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : November 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Belatacept + Everolimus
Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; belatacept (infusion) regimen of 10 mg/kg i.v. on Day 1, Weeks 1, 2, 4, 8 and 12 post transplant and then a maintenance dose of 5 mg/kg every 4 weeks after 12 weeks post transplant; everolimus (tablet) daily dosing at 3.0 mg/day, 2 divided doses, starting on Day 3 dosing adjusted based on blood sample tests; methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Drug: Thymoglobulin
Other Name: ATG

Drug: Belatacept
Other Name: Nulojix

Drug: Corticosteroids
Other Names:
  • Methylprednisolone
  • Prednisone

Drug: Everolimus(EVL)
Other Names:
  • Certican®
  • Zortress®

Experimental: Tacrolimus + Mycophenolate mofetil
Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; tacrolimus (tablet) daily dosing beginning at 0.1 mg/kg/day, then adjusted based on blood sample tests; MMF (tablet) daily dosing between 0.5 to 2.0 g/day divided in 2 doses (up to 3 g/day if African Americans/Blacks); methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Drug: Thymoglobulin
Other Name: ATG

Drug: mycophenolate mofetil(MMF)
Other Name: CellCept

Drug: Corticosteroids
Other Names:
  • Methylprednisolone
  • Prednisone

Drug: Tacrolimus(TAC)
Other Name: Prograf




Primary Outcome Measures :
  1. Incidence of clinically-suspected biopsy-proven acute rejection (CSBPAR) in the individual treatment groups: Belatacept + EVL, TAC + MMF [ Time Frame: Up to 6 months post-transplantation ]

Secondary Outcome Measures :
  1. The treatment groups will each be compared to one another for all secondary endpoints: Treatment differences, time to and outcomes following acute rejection [ Time Frame: 6, 12 and 24 months post-transplant ]
  2. Proportion of subjects who are alive with a functioning graft, have died, and have lost the graft and the time to these events [ Time Frame: 6, 12, 24 months post-transplant ]
  3. Changes in renal function [ Time Frame: 3, 6, 12 and 24 months post-transplant ]
  4. Percentages of subjects with and characterization of Donor Specific Anti- human leukocyte antigen(HLA) Antibodies [ Time Frame: Day 1 and by 12 and 24 months post-transplantation ]
  5. Safety and tolerability of each treatment regimen [ Time Frame: 6, 12, 24 months post-transplant ]
  6. Incidence of new onset diabetes after transplant, and changes in blood pressure and blood tests for cardiovascular disease [ Time Frame: 6, 12, 24 months post-transplant ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women, aged 18 to 75
  • Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)
  • Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased donor kidney

Exclusion Criteria:

  • Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic Thrombocytopenic Purpura
  • Had a previous graft loss due to acute rejection
  • At increased immunologic risk of graft loss due to panel reactive antibodies (PRA) >20% or need for desensitization therapy
  • Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an extended criteria donor
  • Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m2 for diabetics
  • Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or currently or previously active or inadequately treated latent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137239


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02137239     History of Changes
Other Study ID Numbers: IM103-177
2013-002090-21 ( EudraCT Number )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Prednisone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Everolimus
Sirolimus
Mycophenolic Acid
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Abatacept
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic