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Completed

NCT Number: NCT01820572

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

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, ages 18-75 inclusive
  • Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment
  • Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
  • Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
  • Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 4-formula]

Exclusion criteria

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
  • History of acute rejection (AR) within 3 months prior to enrollment
  • History of antibody mediated rejection
  • Positive T-cell lymphocytotoxic cross match
  • Proteinuria >1 g/day or >0.5 g/day if diabetic

Treatment and study plan

Belatacept

Drug

Other names: BMS 224818, Nulojix®

Tacrolimus

Drug

cyclosporine

Drug

Primary outcomes

  1. Percentage of Participants Who Survive With a Functional Graft at 24 Months

    Time frame: at 24 Months

    Percentage of participants who survive with a functional graft at 24 months post-randomization

Secondary outcomes

  1. Percentage of Participants Who Survive With a Functional Graft at 12 Months

    Time frame: at 12 Months

    Percentage of participants who survive with a functional graft at 12 months post-randomization

  2. Number of Participants With a Biopsy Proven Acute Rejection (BPAR)

    Time frame: at 12 and 24 Months

    The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization

    includes participants with at least one cellular and/or humoral BPAR event.

  3. Number of Participants With Varying Severity of BPAR

    Time frame: at 12 and 24 months

    Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization

  4. Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change

    Time frame: at 12 and 24 months

    Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change

  5. Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change

    Time frame: at 12 and 24 months

    Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change

  6. Mean Calculated Glomerular Filtration Rate (cGFR)

    Time frame: up to 24 months

    Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.

  7. Slope Analysis of cGFR

    Time frame: at 12 and 24 Months

    Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization

  8. Slope Analysis of 1/Serum Creatinine

    Time frame: at 12 and 24 Months

    Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization

  9. Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR

    Time frame: at 12 and 24 Months

    Percentage of participants with > 5% and >10% improvement over baseline cGFR, at 12 and 24 months post-randomization

  10. Mean Urine Protein/ Creatinine Ratio (UPCR)

    Time frame: Up to 24 Months

    Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization

  11. Mean Change From Baseline in Systolic and Diastolic Blood Pressure

    Time frame: at 12 and 24 months

    Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization

  12. Number of Antihypertensive Medications Used to Control Hypertension

    Time frame: at baseline, 12 and 24 Months

    The total number of antihypertensive medications used to control hypertension

  13. Number of Participants With Donor Specific Antibodies (DSA)

    Time frame: at baseline, 12 and 24 months

    Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization

  14. Mean Number of Symptom Occurrence and Symptom Distress

    Time frame: up to 12 Months

    The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization.

    Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.

  15. Number of Participants With an Adverse Event of Special Interest

    Time frame: 24 Months

    Number of participants with an adverse event of special interests. Adverse events of special interest include:

    Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.

  16. Number of Participants With Marked Laboratory Abnormalities

    Time frame: 24 Months

    Number of participants with Marked Laboratory Abnormalities

  17. Mean Change From Baseline in Vital Signs: Heart Rate

    Time frame: at 12 and 24 months

    The mean change from baseline in measured heart rate

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2013
Registry last updated
Jan 5, 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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