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Kidney TransplantationPhase 2NCT02137239

Regimen Optimization Study

A Phase 2 study testing Thymoglobulin, Belatacept and mycophenolate mofetil(MMF) in people with Kidney Transplantation, run by Bristol-Myers Squibb at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Transplantation
What is being tested?
Thymoglobulin, Belatacept and mycophenolate mofetil(MMF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
20 sitesin 2 countries
Study dates
31 Dec 2015to 2 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States17 sites

  • Emory Univeristy

    Atlanta, Georgia, 30322

  • University Of Colorado

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Erie County Medical Center

    Buffalo, New York, 14215

  • University of Virginia

    Charlottesville, Virginia, 22908-0709

  • University Of Illinois

    Chicago, Illinois, 60612

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Central PA Transplant Foundation

    Harrisburg, Pennsylvania, 17104

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06519

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • California Institute Of Renal Research

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl

    Seattle, Washington, 98104

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Wake Forest University School Of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Argentina3 sites

  • Clinica Privada Velez Sarsfield

    Córdoba, 5016

  • Sanatorio Parque S.A.

    Rosario, Santa Fe Province, 2000

  • Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares

    Sante Fe, 3000

Other trials in Argentina

About this study

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

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.

Read the detailed description

Calcineurin inhibitor (CNI)

Being tested
Thymoglobulin, Belatacept, mycophenolate mofetil(MMF), Corticosteroids, Everolimus(EVL)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThymoglobulinDrug

    Also called ATG

  • BelataceptDrug

    Also called Nulojix

  • mycophenolate mofetil(MMF)Drug

    Also called CellCept

  • CorticosteroidsDrug

    Also called Methylprednisolone, Prednisone

  • Everolimus(EVL)Drug

    Also called Certican®, Zortress®

  • Tacrolimus(TAC)Drug

    Also called Prograf

Study groups in NCT02137239
Study groupRoleWhat they receive
Belatacept + EverolimusExperimentalThymoglobulin (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)
Receives: Drug: Thymoglobulin; Drug: Belatacept; Drug: Corticosteroids; Drug: Everolimus(EVL)
Tacrolimus + Mycophenolate mofetilExperimentalThymoglobulin (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)
Receives: Drug: Thymoglobulin; Drug: mycophenolate mofetil(MMF); Drug: Corticosteroids; Drug: Tacrolimus(TAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 Months

Secondary outcomes (27)

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

    Measured: Up to 24 Months

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

    Time to Clinically suspected biopsy proven acute rejection

    Measured: Up to 24 Months

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

    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)

    Measured: At 6, 12 and 24 Months

  4. Treatment Differences in Therapeutic Modalities

    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.

    Measured: at 6, 12 and 24 Months

  5. Number of Participants Who Survive With a Functioning Graft

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

    Measured: At 6, 12 and 24 months

  6. Number of Participants Deaths Post Transplant

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

    Measured: up to 24 months

  7. Number of Participants Who Experience Graft Loss Post Transplant

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

    Measured: At 6, 12 and 24 months

  8. Time to Event: Graft Loss and Death

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

    Measured: Up to 728 Days

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

    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

    Measured: Up 24 Months post-transplant

  10. Median Calculated Glomerular Filtration Rate (cGFR)

    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

    Measured: Up 24 Months post-transplant

  11. Mean Change From Month 3 in cGFR

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

    Measured: Up 24 Months post-transplant

  12. Urine Protein Creatinine Ratio (UPr/Cr)

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

    Measured: Up 24 Months post-transplant

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

    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

    Measured: Up to 24 Months

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

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

    Measured: Up to 24 Months

  15. Percentage of Participants With Adverse Events (AEs)

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

    Measured: Up to 24 months Post-Transplant

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

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

    Measured: Up to 24 months Post-Transplant

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

    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

    Measured: Up to 24 Months

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

    Percentage of participants with laboratory tests with marked laboratory abnormalities

    Measured: At 24 Months

  19. Mean and Mean Change From Baseline in Blood Glucose

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

    Measured: Up to 24 months

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

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

    Measured: Up to 24 months

  21. Percentage of Participants With New Onset Diabetes After Transplant

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

    Measured: up to 24 months

  22. Absolute Values of Blood Pressure: Mean

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

    Measured: Up to 24 Months

  23. Absolute Values of Blood Pressure: Median

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

    Measured: Up to 24 Months

  24. Mean Changes From Baseline Values for Blood Pressure

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

    Measured: Up to 24 Months

  25. Absolute Values of Fasting Lipid Values: Mean

    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)

    Measured: Up to 24 Months

  26. Absolute Values of Fasting Lipid Values: Median

    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)

    Measured: Up to 24 Months

  27. Mean Changes From Baseline Values of Lipid Values

    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)

    Measured: at months 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2014 (estimated)
  2. Study start31 Dec 2015
  3. Primary completion2 May 2019
  4. Study completion2 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02137239
Sponsor's protocol ID
IM103-177
Other IDs
2013-002090-21
Status last verified
May 2021
First submitted
12 May 2014
Last updated
22 Jun 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thymoglobulin, Belatacept and mycophenolate mofetil(MMF) in people with Kidney Transplantation, run by Bristol-Myers Squibb at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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