A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01820572 |
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Recruitment Status :
Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : May 23, 2018
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Transplantation | Drug: Belatacept Drug: Tacrolimus Drug: Cyclosporine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 440 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression |
| Actual Study Start Date : | March 27, 2013 |
| Estimated Primary Completion Date : | January 9, 2020 |
| Estimated Study Completion Date : | January 10, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Belatacept
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Belatacept
Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
|
Drug: Belatacept
Other Names:
|
|
Active Comparator: CNI
Tacrolimus 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 |
Drug: Tacrolimus Drug: Cyclosporine |
Primary Outcome Measures :
- Proportion of subjects who survive with a functional graft at 24 months post randomization [ Time Frame: 24 months ]
Secondary Outcome Measures :
- Patient and Graft Survival - Proportion of subjects who survive with a functional graft at 12 months post-randomization [ Time Frame: 12 month ]
- Incidence of acute rejection (AR) post-randomization [ Time Frame: 12 and 24 months ]
- Severity of AR post-randomization [ Time Frame: 12 and 24 months ]
- Renal Function - Mean change in cGFR (MDRD) from baseline to 12 and 24 months post-randomization (% and absolute) [ Time Frame: Baseline (Day 1) to 12 and 24 months ]
- Renal Function - Slopes of cGFR and 1/serum creatinine respectively from baseline as well as Month 3 to 12 and 24 months post-randomization [ Time Frame: Baseline (Day 1), 3 to 12 and 24 months ]
- Renal Function - Proportion of subjects with >5% and >10% improvement over baseline in cGFR at 12 and 24 months post-randomization [ Time Frame: 12 and 24 months ]
- Renal Function - Urine protein/creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post-randomization [ Time Frame: Baseline (Day 1), 3, 6, 12 and 24 months ]
- Hypertension - Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post-randomization, and intensity of anti-hypertensive treatment regimens from baseline to 12 and 24 months [ Time Frame: Baseline (Day 1) to 12 and 24 months ]
- Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [ Time Frame: 12 and 24 Months ]
- Symptom occurrence and symptom distress measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSDS-R 59) at baseline, Week 6, and 3, 6, and 12 months post-randomization [ Time Frame: Baseline (Day 1), Week 6 and 3, 6 and 12 months ]
- Safety and tolerability of a Belatacept-based immunosuppressive regimen-Proportions and incidence rates of all AEs, AEs of special interest, Clinically significant changes in vital signs, Laboratory test abnormalities, Clinically tolerability of the drug [ Time Frame: 12 and 24 Months ]AE = Adverse events
Information from the National Library of Medicine
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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, 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
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): NCT01820572
Hide Study Locations
Locations
| United States, Alabama | |
| UAB Division of Nephrology | |
| Birmingham, Alabama, United States, 352940006 | |
| United States, Arizona | |
| Mayo Clinic Hospital | |
| Phoenix, Arizona, United States, 85027 | |
| United States, California | |
| Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute | |
| Loma Linda, California, United States, 92354 | |
| Keck Medical Center of USC (PI Address) | |
| Los Angeles, California, United States, 90033 | |
| Cedars-Sinai Medical Center-Kidney and Pancreas Transplant Center | |
| Los Angeles, California, United States, 90048 | |
| Transplant Research Institute (PI Address) | |
| Los Angeles, California, United States, 90057 | |
| UCLA Kidney Transplant Research Office | |
| Los Angeles, California, United States, 90095-6984 | |
| University of California, San Francisco (UCSF)-Kidney Transplant Service | |
| Sacramento, California, United States, 95817 | |
| California Institute Of Renal Research | |
| San Diego, California, United States, 92123 | |
| California Pacific Medical Center, Depart of Transplantation (PI Address) | |
| San Francisco, California, United States, 94115 | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| University of Colorado Denver (PI Address) | |
| Aurora, Colorado, United States, 80045 | |
| Denver Nephrologists, PC | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Yale University School of Medicine (Study Supplies Address) | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Florida | |
| Florida Hospital Transplant Institute (PI Address) | |
| Orlando, Florida, United States, 32804 | |
| Central Pharmacy | |
| Saint Petersburg, Florida, United States, 33716 | |
| Tampa General Medicine Group | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Medical College of Georgia at Augusta University | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| RUSH University Transplant Program (PI Address) | |
| Chicago, Illinois, United States, 60612 | |
| United States, Iowa | |
| University of Iowa Health Care (PI Address) | |
| Iowa City, Iowa, United States, 52240 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center, Cancer Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Transplant Program | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Henry Ford's Transplant Institute | |
| Detroit, Michigan, United States, 48202 | |
| St. Clair Nephrology Research | |
| Roseville, Michigan, United States, 48066 | |
| United States, Minnesota | |
| Local Institution | |
| Rochester, Minnesota, United States, 55905 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington Univ School of Med | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University or Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68105 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07006 | |
| United States, New York | |
| University of Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Recanati/Miller Transplantation Institue (PI Address) | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Carolinas Medical Center (PI Address) | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina Univ Nephrology Clin Res. Lab | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center | |
| Cleveland, Ohio, United States, 44106-5055 | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Central PA Transplant Foundation | |
| Harrisburg, Pennsylvania, United States, 17104 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Penn Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15217 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina, SCTR Research Nexus | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Methodist University Hospital Transplant Institute (PI Address) | |
| Memphis, Tennessee, United States, 38104 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232-4753 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-9236 | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 85246 | |
| Baylor All Saints Medical Center at Ft. Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Depart of Nephrology (PI Address) | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Commonwealth University Medical Center | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Swedish Medical Center-Swedish Organ Transplant and Liver Center | |
| Seattle, Washington, United States, 98104 | |
| CHU Rangueil | |
| Seattle, Washington, United States, 98122 | |
| University of Washington Medical Center (PI Address & Study Supplies Address) | |
| Seattle, Washington, United States, 98195 | |
| Providence Sacred Heart Medical Center and Childrens Hospital | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| University of Wisconsin School of Medicine and Public Health (PI Address) | |
| Madison, Wisconsin, United States, 53792 | |
| Medical College of WI Froedtert Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| Local Institution | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1093 | |
| Local Institution | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425 | |
| Local Institution | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT | |
| Local Institution | |
| La Plata, Buenos Aires, Argentina, 1900 | |
| Local Institution | |
| Ciudad De Mendoza, Mendoza, Argentina, 5501 | |
| Local Institution | |
| Rosario, Santa FE, Argentina, Santa Fe, 2000 | |
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| Buenos Aires, Argentina, 1155 | |
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| Buenos Aires, Argentina, C1425 ASS | |
| Local Institution | |
| Cordoba, Argentina, 5016 | |
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| Santa Fe, Argentina, 3000 | |
| Austria | |
| Local Institution | |
| Feldkirch, Austria, 6800 | |
| Local Institution | |
| Graz, Austria, 8036 | |
| Local Institution | |
| Innsbruck, Austria, 6020 | |
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| Linz, Austria, 4020 | |
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| Wien, Austria, A-1070 | |
| Colombia | |
| Local Institution | |
| Bogota, Colombia | |
| Local Institution | |
| Cali, Colombia | |
| France | |
| Local Institution | |
| Bordeaux, France, 33076 | |
| Local Institution | |
| Brest, France, 29609 | |
| Local Institution | |
| Creteil, France, 94010 | |
| Local Institution | |
| La Tronche, France, 38700 | |
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| Le Kremlin-Bicetre, France, 94270 | |
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| Lyon, France, 69003 | |
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| Paris Cedex 10, France, 75475 | |
| Local Institution | |
| Paris, France, 75011 | |
| Local Institution | |
| Rouen, France, 76031 | |
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| Strasbourg, France, 67091 | |
| Germany | |
| Local Institution | |
| Berlin, Germany, 10117 | |
| Local Institution | |
| Berlin, Germany, 12200 | |
| Local Institution | |
| Dresden, Germany, 01307 | |
| Local Institution | |
| Erlangen, Germany, 91054 | |
| Local Institution | |
| Essen, Germany, 45147 | |
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| Frankfurt / Main, Germany, 60590 | |
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| Hamburg, Germany, 20246 | |
| Local Institution | |
| Hannover, Germany, 30625 | |
| Local Institution | |
| Heidelberg, Germany, 69120 | |
| Local Institution | |
| Kiel, Germany, 24105 | |
| Local Institution | |
| Lubeck, Germany, 23538 | |
| Local Institution | |
| Mannheim, Germany, 68167 | |
| Local Institution | |
| Muenchen, Germany, 81675 | |
| Local Institution | |
| Muenster, Germany, 48147 | |
| Local Institution | |
| Regensburg, Germany, 93053 | |
| Local Institution | |
| Wurzburg, Germany, 97080 | |
| Greece | |
| University of Virginia Health System (PI Address) | |
| Ioannina, Greece, 45500 | |
| Netherlands | |
| Local Institution | |
| Amsterdam, Netherlands, 1081HV | |
| Local Institution | |
| Amsterdam, Netherlands, 1105 AZ | |
| Local Institution | |
| Groningen, Netherlands, 9700RB | |
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| Leiden, Netherlands, 2333 ZA | |
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| Nijmegen, Netherlands, 6525 GA | |
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| Utrecht, Netherlands, 3584 CX | |
| Norway | |
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| Oslo, Norway, 0027 | |
| Local Institution | |
| Toensberg Norge, Norway, 3103 | |
| Sweden | |
| Local Institution | |
| Goteborg, Sweden, S-41345 | |
| Local Institution | |
| Stockholm, Sweden, 14186 | |
| Local Institution | |
| Uppsala, Sweden, 75185 | |
| Switzerland | |
| Local Institution | |
| Bern, Switzerland, 3010 | |
| Local Institution | |
| Geneve 14, Switzerland, 1211 | |
| Local Institution | |
| Zurich, Switzerland, 8091 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01820572 History of Changes |
| Other Study ID Numbers: |
IM103-116 2012-001314-42 ( EudraCT Number ) |
| First Posted: | March 29, 2013 Key Record Dates |
| Last Update Posted: | May 23, 2018 |
| Last Verified: | May 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Tacrolimus Cyclosporins Cyclosporine Abatacept Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |