AzTrials
AzTrials

Kidney TransplantationPhase 3NCT01820572

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

A Phase 3 study testing Belatacept, Tacrolimus and Cyclosporine in people with Kidney Transplantation, run by Bristol-Myers Squibb at 117 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

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. 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?
Belatacept, Tacrolimus and Cyclosporine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
117 sitesin 10 countries
Study dates
27 Mar 2013to 24 Oct 2019
Phase
Phase 3
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, 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]

Who cannot join

  • 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

Trial locations and contacts

117 sites in 10 countries.

117 sites in 10 countries

United States60 sites

  • Emory University

    Atlanta, Georgia

  • Medical College of Georgia at Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Denver (PI Address)

    Aurora, Colorado, 80045

  • UAB Division of Nephrology

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Buffalo

    Buffalo, New York, 14215

  • Medical University of South Carolina, SCTR Research Nexus

    Charleston, South Carolina, 29425

  • Carolinas Medical Center (PI Address)

    Charlotte, North Carolina, 28203

  • University of Virginia Health System (PI Address)

    Charlottesville, Virginia, 22903

  • RUSH University Transplant Program (PI Address)

    Chicago, Illinois, 60612

  • University of Wisconsin School of Medicine and Public Health (PI Address)

    Chicago, Illinois

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-5055

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Denver Nephrologists, PC

    Denver, Colorado, 80218

  • Henry Ford's Transplant Institute

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Baylor All Saints Medical Center at Ft. Worth

    Fort Worth, Texas, 76104

  • East Carolina Univ Nephrology Clin Res. Lab

    Greenville, North Carolina, 27834

  • Central PA Transplant Foundation

    Harrisburg, Pennsylvania, 17104

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • University of Iowa Health Care (PI Address)

    Iowa City, Iowa, 52242-1101

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07006

  • Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute

    Loma Linda, California, 92354

  • UCLA Kidney Transplant Research Office

    Los Angeles, California, 90024

  • Keck Medical Center of USC (PI Address)

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Transplant Research Institute (PI Address)

    Los Angeles, California, 90057

  • Methodist University Hospital Transplant Institute (PI Address)

    Memphis, Tennessee, 38104

  • Medical College of WI Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center- GI Research Office

    Nashville, Tennessee, 37212-1375

  • Yale Medical Group

    New Haven, Connecticut, 06520

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Recanati/Miller Transplantation Institue (PI Address)

    New York, New York, 10029

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • University or Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Florida Hospital Transplant Institute (PI Address)

    Orlando, Florida, 32804

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85027

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213-2582

  • Maine Transplant Program

    Portland, Maine, 04102

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298-0160

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066

  • University of California, San Francisco (UCSF)-Kidney Transplant Service

    Sacramento, California, 95817

  • University of Utah Depart of Nephrology (PI Address)

    Salt Lake City, Utah, 84132

  • California Institute Of Renal Research

    San Diego, California, 92123

  • California Pacific Medical Center, Depart of Transplantation (PI Address)

    San Francisco, California, 94115

  • UCSF Medical Center

    San Francisco, California, 94143-0116

  • Swedish Medical Center-Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • University of Washington Medical Center (PI Address & Study Supplies Address)

    Seattle, Washington, 98195

  • Providence Sacred Heart Medical Center and Childrens Hospital

    Spokane, Washington, 99204

  • Washington Univ School of Med

    St Louis, Missouri, 63110

  • Central Pharmacy

    St. Petersburg, Florida, 33716

  • Tampa General Medicine Group

    Tampa, Florida, 33606

Other trials in United States

Germany15 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Dresden, 01307

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45147

  • Local Institution

    Frankfurt am Main

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hanover, 30625

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Kiel, 24105

  • Local Institution

    Lübeck, 23538

  • Local Institution

    Mannheim, 68167

  • Local Institution

    München, 81675

  • Local Institution

    Münster, 48149

  • Local Institution

    Regensburg, 93053

  • Local Institution

    Würzburg, 97080

Other trials in Germany

France11 sites

  • Local Institution

    Bois-Guillaume, 76230

  • Local Institution

    Bordeaux, 33076

  • Local Institution

    Brest, 29609

  • Local Institution

    Créteil, 94010

  • Local Institution

    Grenoble

  • Local Institution

    Le Kremilin Bicretre, 942875

  • Local Institution

    Lyon, 69437

  • Local Institution

    Paris, Cedex 15

  • Local Institution

    Paris, 75475

  • Local Institution

    Strasbourg, 67091

  • CHU Rangueil

    Toulouse, 31059

Other trials in France

Argentina10 sites

  • Local Institution

    Buenos Aires, 1155

  • Local Institution

    CABA, 1425

  • Local Institution

    Cardoba, Córdoba Province, 5016

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1093

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT

  • Local Institution

    Córdoba, X5016KEH

  • Local Institution

    Mendoza, Buenos Aires, M5501ACJ

  • Local Institution

    Rosario, Santa Fe Province, Santa Fe, 2000

  • Local Institution

    Santa Fe, 3000

Other trials in Argentina

Netherlands6 sites

  • Local Institution

    Amsterdam, 1081HV

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Groningen, 9700RB

  • Local Institution

    Leiden, 2333 ZA

  • Local Institution

    Nijmegen, 6525 GA

  • Local Institution

    Utrecht, 3584 CX

Other trials in Netherlands

Austria5 sites

  • Local Institution

    Feldkirch, 6800

  • Local Institution

    Graz, 8036

  • Local Institution

    Innsbruck, 6020

  • Local Institution

    Linz, 4020

  • Local Institution

    Vienna, 1090

Other trials in Austria

Sweden3 sites

  • Local Institution

    Gothenburg, S-41345

  • Local Institution

    Stockholm, 14186

  • Local Institution

    Uppsala, 75185

Other trials in Sweden

Switzerland3 sites

  • Local Institution

    Bern, 3010

  • Local Institution

    Geneva, 1211

  • Local Institution

    Zurich, 8091

Other trials in Switzerland

Colombia2 sites

  • Local Institution

    Bogotá

  • Local Institution

    Cali, Valle del Cauca Department

Other trials in Colombia

Norway2 sites

  • Local Institution

    Oslo, 04224

  • Local Institution

    Toensberg Norge, 3103

Other trials in Norway

About this study

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

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.

Being tested
Belatacept, Tacrolimus, Cyclosporine

What participants receive

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

Study groups in NCT01820572
Study groupRoleWhat they receive
BelataceptExperimentalBelatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
Receives: Drug: Belatacept
CNIActive comparatorTacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months
Receives: Drug: Tacrolimus; Drug: Cyclosporine

What is being measured

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

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

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

    Measured: at 24 Months

Secondary outcomes (17)

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

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

    Measured: at 12 Months

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

    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.

    Measured: at 12 and 24 Months

  3. Number of Participants With Varying Severity of BPAR

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

    Measured: at 12 and 24 months

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

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

    Measured: at 12 and 24 months

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

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

    Measured: at 12 and 24 months

  6. Mean Calculated Glomerular Filtration Rate (cGFR)

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

    Measured: up to 24 months

  7. Slope Analysis of cGFR

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

    Measured: at 12 and 24 Months

  8. Slope Analysis of 1/Serum Creatinine

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

    Measured: at 12 and 24 Months

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

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

    Measured: at 12 and 24 Months

  10. Mean Urine Protein/ Creatinine Ratio (UPCR)

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

    Measured: Up to 24 Months

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

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

    Measured: at 12 and 24 months

  12. Number of Antihypertensive Medications Used to Control Hypertension

    The total number of antihypertensive medications used to control hypertension

    Measured: at baseline, 12 and 24 Months

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

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

    Measured: at baseline, 12 and 24 months

  14. Mean Number of Symptom Occurrence and Symptom Distress

    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.

    Measured: up to 12 Months

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

    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.

    Measured: 24 Months

  16. Number of Participants With Marked Laboratory Abnormalities

    Number of participants with Marked Laboratory Abnormalities

    Measured: 24 Months

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

    The mean change from baseline in measured heart rate

    Measured: at 12 and 24 months

Timeline

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

  1. First posted29 Mar 2013 (estimated)
  2. Study start27 Mar 2013
  3. Primary completion24 Oct 2019
  4. Study completion24 Oct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01820572
Sponsor's protocol ID
IM103-116
Other IDs
2012-001314-42
Status last verified
Dec 2020
First submitted
14 Mar 2013
Last updated
5 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Budde K, Prashar R, Haller H, Rial MC, Kamar N, Agarwal A, de Fijter JW, Rostaing L, Berger SP, Djamali A, Leca N, Allamassey L, Gao S, Polinsky M, Vincenti F. Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial. J Am Soc Nephrol. 2021 Dec 1;32(12):3252-3264. doi: 10.1681/ASN.2021050628. Epub 2021 Dec 1.

    PubMed 34706967

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belatacept, Tacrolimus and Cyclosporine in people with Kidney Transplantation, run by Bristol-Myers Squibb at 117 sites in 10 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 5 inclusion and 5 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Germany, France, Argentina, Netherlands and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Jan 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 Participants Who Survive With a Functional Graft at 24 Months (time frame: at 24 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 NCT01820572, which also lists 1 linked publication.

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 5 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in