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A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
This study is currently recruiting participants.
Verified May 2017 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01820572
First received: March 14, 2013
Last updated: June 9, 2017
Last verified: May 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Kidney Transplantation | Drug: Belatacept Drug: Tacrolimus Drug: Cyclosporine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression |
Resource links provided by NLM:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Belatacept
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
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
| Estimated Enrollment: | 440 |
| Actual Study Start Date: | March 27, 2013 |
| Estimated Study Completion Date: | January 9, 2020 |
| Estimated Primary Completion Date: | January 9, 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820572
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01820572
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
| Contact: First line of the email MUST contain NCT# and Site #. |
Hide Study Locations
Locations
| United States, Alabama | |
| Uab Division Of Nephrology | Recruiting |
| Birmingham, Alabama, United States, 352940006 | |
| Contact: Roslyn Mannon, Site 0071 205-996-9632 | |
| Ucla Kidney Transplant Research Office | Recruiting |
| Los Angeles, Alabama, United States, 90204 | |
| Contact: Suphamai Bunnapradist, Site 0090 310-794-8516 | |
| United States, Arizona | |
| Mayo Clinic Hospital | Recruiting |
| Phoenix, Arizona, United States, 85027 | |
| Contact: Hasan Ahmad Khamash, Site 0112 | |
| United States, California | |
| Loma Linda University (Pi Address) | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Arputharaj Kore, Site 0068 | |
| Keck Medical Center Of Usc (Pi Address) | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Yasir Qazi, Site 0080 | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Stanley Jordan, Site 0091 | |
| Transplant Research Institute (Pi Address) | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Contact: Tariq Shah, Site 0077 213-384-4874 | |
| University Of California, San Francisco (Ucsf)-Kidney Transplant Service | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Brian Gallay, Site 0086 | |
| California Institute Of Renal Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Steven Steinberg, Site 0001 858-637-4600 | |
| California Pacific Medical Center, Depart Of Transplantation (Pi Address) | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Ram Peddi, Site 0023 | |
| Ucsf Medical Center | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Flavio Vincenti, Site 0096 | |
| United States, Colorado | |
| University Of Colorado Denver (Pi Address) | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Alexander Wiseman, Site 0087 | |
| Denver Nephrologists, Pc | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Bradley Marder, Site 0003 | |
| United States, Connecticut | |
| Yale University School Of Medicine (Study Supplies Address) | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Sanjay Kulkarni, Site 0015 | |
| United States, Florida | |
| Florida Hospital Transplant Institute (Pi Address) | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Contact: Bobby Nibhanupudy, Site 0027 | |
| Central Pharmacy | Recruiting |
| Saint Petersburg, Florida, United States, 33716 | |
| Contact: Anne Kruk, Site 0101 | |
| Tampa General Medicine Group | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Victor Bowers, Site 0017 | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Stephan Pastan, Site 0010 404-712-8936 | |
| Vanderbilt University Medical Center | Recruiting |
| Atlanta, Georgia, United States, 31192 | |
| Contact: J. Harold Helderman, Site 0074 | |
| Medical College Of Georgia At Augusta University | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Carlos Zayas-Montalvo, Site 0111 706-721-9546 | |
| United States, Illinois | |
| Rush University Transplant Program (Pi Address) | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Stephen Jensik, Site 0089 312-563-4249 | |
| United States, Iowa | |
| University Of Iowa Health Care (Pi Address) | Recruiting |
| Iowa City, Iowa, United States, 52240 | |
| Contact: Daniel Katz, Site 0095 319-467-5677 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center, Cancer Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Rubin Zhang, Site 0115 | |
| United States, Maine | |
| Maine Medical Center | Recruiting |
| Portland, Maine, United States, 04102 | |
| Contact: John Vella, Site 0016 207-662-7191 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Winfred Williams, Site 0006 | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Rohini Prashar, Site 0014 313-916-4596 | |
| Renaissance Renal Research Institute, Llc (Pi, Sc, And Drug Ship Address) | Recruiting |
| Detroit, Michigan, United States, 48236 | |
| Contact: David Butcher, Site 0012 | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mark Stegall, Site 0109 | |
| United States, Missouri | |
| Washington Univ School Of Med | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Daniel Brennan, Site 0076 314-362-4109 | |
| United States, Nebraska | |
| University Or Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Clifford Miles, Site 0117 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | Recruiting |
| Livingston, New Jersey, United States, 07006 | |
| Contact: Anup Patel, Site 0084 | |
| United States, New York | |
| University Of Buffalo | Recruiting |
| Buffalo, New York, United States, 14215 | |
| Contact: Mareena Zachariah, Site 0078 | |
| Recanati/Miller Transplantation Institue (Pi Address) | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Sander Florman, Site 0002 | |
| United States, North Carolina | |
| Carolinas Medical Center (Pi Address) | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Paul Gores, Site 0022 | |
| Duke University Medical Center (Pi Address) | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Debra Sudan, Site 0007 919-681-6898 | |
| East Carolina Univ Nephrology Clin Res. Lab (Sc Address) | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Paul Bolin, Site 0009 | |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Donald Hricik, Site 0106 | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Richard Fatica, Site 0020 216-444-3256 | |
| United States, Pennsylvania | |
| Central Pa Transplant Foundation (Pi And Sc Address) | Recruiting |
| Harrisburg, Pennsylvania, United States, 17101 | |
| Contact: Harold Yang, Site 0088 | |
| Drexel University College Of Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Karthik Ranganna, Site 0085 | |
| Penn Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Roy Bloom, Site 0005 | |
| University Of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15217 | |
| Contact: Sundaram Hariharan, Site 0025 | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Reginald Gohh, Site 0079 | |
| United States, South Carolina | |
| Medical University Of South Carolina, Sctr Research Nexus | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Maria Aurora Posadas Salas, Site 0026 | |
| United States, Tennessee | |
| Methodist University Hospital | Recruiting |
| Memphis, Tennessee, United States, 38104 | |
| Contact: Luis , Md Campos, Site 0073 901-516-2031 | |
| United States, Texas | |
| William P. Clements Jr University Hospital | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Malcolm Macconmara, Site 0113 | |
| Baylor University Medical Center | Recruiting |
| Dallas, Texas, United States, 85246 | |
| Contact: Kim Rice, Site 0083 | |
| Baylor All Saints Medical Center At Ft. Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Bernard Fischbach, Site 0094 817-922-2571 | |
| Baylor College Of Medicine | Completed |
| Houston, Texas, United States, 77030 | |
| Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: John (Steve) Bynon, Site 0108 | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Richard Knight, Site 0075 | |
| Local Institution | Not yet recruiting |
| San Antonio, Texas, United States, 78284 | |
| Contact: Site 0110 | |
| United States, Utah | |
| University Of Utah Depart Of Nephrology (Pi Address) | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Fuad Shihab, Site 0069 | |
| United States, Virginia | |
| University Of Virginia Health System (Pi Address) | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Avinash Agarwal, Site 0011 | |
| Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Thomas Mccune, Site 0013 757-388-5480 | |
| Virginia Commonwealth University Medical Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Gaurav Gupta, Site 0103 | |
| United States, Washington | |
| Swedish Medical Center - Swedish Organ Transplant And Liver Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Nelson Goes, Site 0082 | |
| University Of Washington Medical Center (Pi Address & Study Supplies Address) | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Nicolae , Md Leca, Site 0019 | |
| Providence Sacred Heart Medical Center And Childrens Hospital | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Samer Bani Hani, Site 0021 509-474-4302 | |
| United States, Wisconsin | |
| University Of Wisconsin School Of Medicine And Public Health (Pi Address) | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Arjang Djamali, Site 0097 608-262-1632 | |
| Medical College Of Wi- Froedtert Hospital | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Ehab Saad, Site 0004 | |
| Argentina | |
| Local Institution | Recruiting |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425 | |
| Contact: Site 0053 | |
| Local Institution | Recruiting |
| Cb Rdoba, Cordoba, Argentina, X5016LIG | |
| Contact: Site 0046 | |
| Local Institution | Recruiting |
| Ciudad De Mendoza, Mendoza, Argentina, 5501 | |
| Contact: Site 0107 | |
| Local Institution | Recruiting |
| Rosario, Santa Fe, Argentina, Santa Fe, 2000 | |
| Contact: Site 0060 | |
| Local Institution | Recruiting |
| Buenos Aires, Argentina, 1093 AAS | |
| Contact: Site 0131 | |
| Local Institution | Recruiting |
| Buenos Aires, Argentina, 1155 | |
| Contact: Site 0055 | |
| Local Institution | Recruiting |
| Buenos Aires, Argentina, C1425 ASS | |
| Contact: Site 0057 | |
| Local Institution | Recruiting |
| Caba, Argentina | |
| Contact: Site 0093 | |
| Local Institution | Recruiting |
| Cordoba, Argentina, 5016 | |
| Contact: Site 0104 | |
| Local Institution | Recruiting |
| Santa Fe, Argentina, S3000EPV | |
| Contact: Site 0070 | |
| Austria | |
| Local Institution | Recruiting |
| Feldkirch, Austria, 6800 | |
| Contact: Site 0044 | |
| Local Institution | Active, not recruiting |
| Graz, Austria, 8036 | |
| Local Institution | Recruiting |
| Innsbruck, Austria, 6020 | |
| Contact: Site 0047 | |
| Local Institution | Recruiting |
| Linz, Austria, 4020 | |
| Contact: Site 0052 | |
| Local Institution | Recruiting |
| Wien, Austria, A-1070 | |
| Contact: Site 0061 | |
| Colombia | |
| Local Institution | Recruiting |
| Bogota, Colombia | |
| Contact: Site 0050 | |
| Local Institution | Completed |
| Cali, Colombia | |
| France | |
| Local Institution | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Site 0121 | |
| Local Institution | Recruiting |
| Brest, France, 29609 | |
| Contact: Site 0127 | |
| Local Institution | Recruiting |
| Creteil, France, 94010 | |
| Contact: Site 0120 | |
| Local Institution | Recruiting |
| La Tronche, France, 38700 | |
| Contact: Site 0124 | |
| Local Institution | Recruiting |
| Le Kremlin Bicetre Cedex, France, 94275 | |
| Contact: Site 0122 | |
| Local Institution | Recruiting |
| Lyon, France, 69003 | |
| Contact: Site 0125 | |
| Local Institution | Recruiting |
| Paris Cedex 10, France, 75475 | |
| Contact: Site 0126 | |
| Local Institution | Recruiting |
| Paris, France, 75011 | |
| Contact: Site 0123 | |
| Local Institution | Recruiting |
| Rouen, France, 76031 | |
| Contact: Site 0130 | |
| Local Institution | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Site 0119 | |
| Chu Rangueil | Recruiting |
| Toulouse, France, 31400 | |
| Contact: Nassim Kamar, Site 0129 | |
| Germany | |
| Local Institution | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Site 0041 | |
| Local Institution | Active, not recruiting |
| Dresden, Germany, 01307 | |
| Local Institution | Recruiting |
| Erlangen, Germany, 91054 | |
| Contact: Site 0065 | |
| Local Institution | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Site 0066 | |
| Local Institution | Recruiting |
| Frankfurt / Main, Germany, 60590 | |
| Contact: Site 0037 | |
| Local Institution | Active, not recruiting |
| Hamburg, Germany, 20246 | |
| Local Institution | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: Site 0035 | |
| Local Institution | Recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Site 0058 | |
| Local Institution | Recruiting |
| Kiel, Germany, 24105 | |
| Contact: Site 0033 | |
| Local Institution | Active, not recruiting |
| Luebeck, Germany, 23538 | |
| Local Institution | Recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Site 0043 | |
| Local Institution | Recruiting |
| Muenchen, Germany, 81675 | |
| Contact: Site 0099 | |
| Local Institution | Recruiting |
| Munster, Germany, 48149 | |
| Contact: Site 0059 | |
| Local Institution | Recruiting |
| Regensburg, Germany, 93053 | |
| Contact: Site 0029 | |
| Local Institution | Not yet recruiting |
| Ulm, Germany, 89081 | |
| Contact: Site 0116 | |
| Local Institution | Active, not recruiting |
| Wuerzburg, Germany, 97080 | |
| Netherlands | |
| Local Institution | Recruiting |
| Amsterdam, Netherlands, 1081HV | |
| Contact: Site 0100 | |
| Local Institution | Active, not recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Local Institution | Recruiting |
| Groningen, Netherlands, 9700RB | |
| Contact: Site 0056 | |
| Local Institution | Recruiting |
| Leiden, Netherlands, 2333 ZA | |
| Contact: Site 0031 | |
| Local Institution | Recruiting |
| Nijmegen, Netherlands, 6525 GA | |
| Contact: Site 0038 | |
| Local Institution | Active, not recruiting |
| Utrecht, Netherlands, 3584 cx | |
| Norway | |
| Local Institution | Recruiting |
| Oslo, Norway, 0027 | |
| Contact: Site 0039 | |
| Local Institution | Recruiting |
| Toensberg Norge, Norway, 3103 | |
| Contact: Site 0118 | |
| Sweden | |
| Local Institution | Recruiting |
| Goteborg, Sweden, S-41345 | |
| Contact: Site 0049 | |
| Local Institution | Active, not recruiting |
| Hudding, Sweden, SE-141 86 | |
| Local Institution | Active, not recruiting |
| Uppsala, Sweden, 751 85 | |
| Switzerland | |
| Local Institution | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Site 0042 | |
| Local Institution | Not yet recruiting |
| Geneve 14, Switzerland, 1211 | |
| Contact: Site 0034 | |
| Local Institution | Not yet recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Site 0081 | |
| Local Institution | Not yet recruiting |
| ZB rich, Switzerland, 8091 | |
| Contact: Site 0032 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
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 ) |
| Study First Received: | March 14, 2013 |
| Last Updated: | June 9, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Tacrolimus Abatacept Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |
ClinicalTrials.gov processed this record on June 21, 2017