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Completed

NCT Number: NCT02137239

Regimen Optimization Study

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanatorio Parque S.A., Rosario, Santa Fe Province, Argentina

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About this study

Calcineurin inhibitor (CNI)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymoglobulin

Drug

Other names: ATG

Belatacept

Drug

Other names: Nulojix

mycophenolate mofetil(MMF)

Drug

Other names: CellCept

Corticosteroids

Drug

Other names: Methylprednisolone, Prednisone

Everolimus(EVL)

Drug

Other names: Certican®, Zortress®

Tacrolimus(TAC)

Drug

Other names: Prograf

Primary outcomes

  1. Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months

    Time frame: 6 Months

    Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months

Secondary outcomes

  1. Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months

    Time frame: Up to 24 Months

    Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months

    Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B).

  2. Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).

    Time frame: Up to 24 Months

    Time to Clinically suspected biopsy proven acute rejection

  3. Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection

    Time frame: At 6, 12 and 24 Months

    Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant.

    Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)

  4. Treatment Differences in Therapeutic Modalities

    Time frame: at 6, 12 and 24 Months

    Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received.

  5. Number of Participants Who Survive With a Functioning Graft

    Time frame: At 6, 12 and 24 months

    Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant

  6. Number of Participants Deaths Post Transplant

    Time frame: up to 24 months

    Number of participant deaths at 6, 12 and 24 months post transplant

  7. Number of Participants Who Experience Graft Loss Post Transplant

    Time frame: At 6, 12 and 24 months

    Number of all participants who experience graft loss at 6, 12 and 24 months post transplant

  8. Time to Event: Graft Loss and Death

    Time frame: Up to 728 Days

    The Number of days to participant Graft Loss and death for any reason

  9. Absolute Calculated Glomerular Filtration Rate (cGFR): Mean

    Time frame: Up 24 Months post-transplant

    Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula

  10. Median Calculated Glomerular Filtration Rate (cGFR)

    Time frame: Up 24 Months post-transplant

    Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula

  11. Mean Change From Month 3 in cGFR

    Time frame: Up 24 Months post-transplant

    The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant

  12. Urine Protein Creatinine Ratio (UPr/Cr)

    Time frame: Up 24 Months post-transplant

    Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant.

  13. Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)

    Time frame: Up to 24 Months

    Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant

  14. Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)

    Time frame: Up to 24 Months

    Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties.

  15. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to 24 months Post-Transplant

    Percentage of participants with AEs up to 24 months post-transplant

  16. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 24 months Post-Transplant

    Percentage of participants with SAEs up to 24 months post-transplant

  17. Percentage of Participants With Events of Special Interest (ESIs)

    Time frame: Up to 24 Months

    Percentage of participants which have one of the following events of special interest:

    Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion

  18. Percentage of Particpants With Laboratory Test Abnormalities (LTAs)

    Time frame: At 24 Months

    Percentage of participants with laboratory tests with marked laboratory abnormalities

  19. Mean and Mean Change From Baseline in Blood Glucose

    Time frame: Up to 24 months

    Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant

  20. Mean and Mean Change From Baseline in Whole Blood HbA1c

    Time frame: Up to 24 months

    Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant.

  21. Percentage of Participants With New Onset Diabetes After Transplant

    Time frame: up to 24 months

    Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant.

  22. Absolute Values of Blood Pressure: Mean

    Time frame: Up to 24 Months

    Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;

  23. Absolute Values of Blood Pressure: Median

    Time frame: Up to 24 Months

    Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;

  24. Mean Changes From Baseline Values for Blood Pressure

    Time frame: Up to 24 Months

    Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant

  25. Absolute Values of Fasting Lipid Values: Mean

    Time frame: Up to 24 Months

    Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:

    Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

  26. Absolute Values of Fasting Lipid Values: Median

    Time frame: Up to 24 Months

    Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:

    Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

  27. Mean Changes From Baseline Values of Lipid Values

    Time frame: at months 12 and 24

    Mean changes from baseline values in the following:

    Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 13, 2014
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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