A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 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: February 19, 2015
Last verified: October 2014
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
- Incidence of acute rejection (AR) post-randomization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Severity of AR post-randomization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [ Time Frame: 12 and 24 Months ] [ Designated as safety issue: No ]
- Occurrence of 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]AE = Adverse events
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | October 2018 (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 5-10 ng/mL tablet orally according to package insert for 24 months Cyclosporine 100-250 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 |
| Genders Eligible for Study: | Both |
| 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 #. |
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Locations
| United States, Alabama | |
| University Of Alabama At Birmingham (Uab) | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Roslyn Mannon, Site 0071 205-934-7220 | |
| United States, California | |
| Loma Linda University Medical Center-Transplantation Institu | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Arputharaj Kore, Site 0068 909-558-3670 | |
| Cedars Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Rafael Villicana, Site 0091 310-248-6528 | |
| Keck Medical Center Of Usc, Hcc 1 | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Yasir Qazi, Site 0080 323-442-5322 | |
| Transplant Research Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Contact: Tariq Shah, Site 0077 213-384-4874 | |
| University Of California - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Suphamai Bunnapradist, Site 0090 310-794-8516 | |
| University Of California Davis Health System | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Deborah Adey, Site 0086 530-908-6778 | |
| California Institute Of Renal Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Steven Marc Steinberg, Site 0001 858-637-4600 | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Venkat Peddi, Site 0023 415-600-1744 | |
| University Of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Flavio Vincenti, Site 0096 415-353-8380 | |
| United States, Colorado | |
| University Of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Alexander Wiseman, Site 0087 303-724-0396 | |
| Denver Nephrologists | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Bradley A Marder, Site 0003 303-861-4845 | |
| United States, Connecticut | |
| Yale University School Of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Sanjay Kulkarni, Site 0015 203-785-7031 | |
| United States, Florida | |
| Florida Hospital | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Contact: Bobby Nibhanupudy, Site 0027 407-303-2988 | |
| Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Victor Bowers, Site 0017 813-844-5692 | |
| United States, Georgia | |
| Emory Transplant Center | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Stephen Pastan, Site 0010 404-712-1816 | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Stephen C Jensik, Site 0089 312-942-3993 | |
| United States, Iowa | |
| University Of Iowa Health Care | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Daniel Katz, Site 0095 319-356-0578 | |
| 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, Jr, Site 0006 617-724-1270 | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Mariella Ortigosa-Goggins, Site 0014 313-916-4596 | |
| Renaissance Renal Research Institute, Llc | Recruiting |
| Detroit, Michigan, United States, 48236 | |
| Contact: David Butcher, Site 0012 313-886-8787 | |
| United States, Missouri | |
| Washington University School Of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Daniel Brennan, Site 0076 314-362-8351 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Anup Patel, Site 0084 973-322-5142 | |
| United States, New York | |
| Erie County Medical Center | Recruiting |
| Buffalo, New York, United States, 14215 | |
| Contact: Mark Laftavi, Site 0078 716-898-3418 | |
| Recanati/Miller Transplantation Institute | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Sander Florman, Site 0002 212-659-8046 | |
| United States, North Carolina | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Paul F Gores, Site 0022 704-355-6359 | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Debra Sudan, Site 0007 919-681-6898 | |
| East Carolina University | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: Paul Bolin, Site 0009 252-744-3773 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Richard Fatica, Site 0020 216-444-3256 | |
| United States, Pennsylvania | |
| Central Pa Transplant Foundation, Inc. | Recruiting |
| Harrisburg, Pennsylvania, United States, 17104 | |
| Contact: Harold Yang, Site 0088 717-231-8700 | |
| Drexel University College Of Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Karthik Ranganna, Site 0085 267-507-6811 | |
| Penn Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Roy Bloom, Site 0005 215-615-0773 | |
| Upmc | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Sundaram Hariharan, Site 0025 412-864-3781 | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Reginald Gohh, Site 0079 401-444-8598 | |
| United States, South Carolina | |
| Medical University Of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Titte Srinivas, Site 0026 843-792-8824 | |
| United States, Tennessee | |
| Methodist University Hospital | Recruiting |
| Memphis, Tennessee, United States, 38104 | |
| Contact: Luis Campos De La Borbolla, Site 0073 901-516-2031 | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: J. Harold Helderman, Site 0074 615-936-1182 | |
| United States, Texas | |
| Annette C And Harold C Simmons Transplant Institute | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Kim Rice, Site 0083 214-820-1771 | |
| Baylor All Saints Medical Centers | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Bernard Fischbach, Site 0094 817-922-7667 | |
| Baylor College Of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Abbas Rana, Site 0098 832-355-1450 | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Richard Knight, Site 0075 713-441-6396 | |
| United States, Utah | |
| University Of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Faud Shihab, Site 0069 801-585-3845 | |
| United States, Virginia | |
| University Of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Avinash Agarwal, Site 0011 434-982-3665 | |
| Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Thomas Mccune, Site 0013 757-388-5480 | |
| United States, Washington | |
| University Of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Nicolae Leca, Site 0019 206-598-1562 | |
| Swedish Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Nelson Goes, Site 0082 206-215-3063 | |
| Providence Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Samer Bani Hani, Site 0021 509-474-3821 | |
| United States, Wisconsin | |
| University Of Wisconsin School Of Medicine & Public Health | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Arjang Djamali, Site 0097 608-262-7115 | |
| Medical College Of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Brahm Vasudev, Site 0004 414-805-0752 | |
| Argentina | |
| Local Institution | Recruiting |
| Capital Federal, Buenos Aires, Argentina, C1425 ASS | |
| Contact: Site 0057 | |
| Local Institution | Not yet recruiting |
| Capital Federal, Buenos Aires, Argentina, 1155 | |
| Contact: Site 0055 | |
| Local Institution | Recruiting |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425 | |
| Contact: Site 0053 | |
| Local Institution | Recruiting |
| Rosario, Santa Fe, Argentina, 2000 | |
| Contact: Site 0060 | |
| Local Institution | Recruiting |
| Caba, Argentina | |
| Contact: Site 0093 | |
| Local Institution | Recruiting |
| Cordoba, Argentina, X5016LIG | |
| Contact: Site 0046 | |
| Local Institution | Recruiting |
| Santa Fe, Argentina, S3000EPV | |
| Contact: Site 0070 | |
| Austria | |
| Local Institution | Recruiting |
| Feldkirch, Austria, 6800 | |
| Contact: Site 0044 | |
| Local Institution | Recruiting |
| Graz, Austria, 8036 | |
| Contact: Site 0054 | |
| Local Institution | Recruiting |
| Innsbruck, Austria, 6020 | |
| Contact: Site 0047 | |
| Local Institution | Recruiting |
| Linz, Austria, 4020 | |
| Contact: Site 0052 | |
| Local Institution | Recruiting |
| Vienna, Austria, 1070 | |
| Contact: Site 0061 | |
| Colombia | |
| Local Institution | Recruiting |
| Bogota, Cundinamarca, Colombia, ----- | |
| Contact: Site 0050 | |
| Local Institution | Recruiting |
| Cali, Valle del Cauca, Colombia, ----- | |
| Contact: Site 0048 | |
| Germany | |
| Local Institution | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Site 0041 | |
| Local Institution | Not yet recruiting |
| Berlin, Germany, 12203 | |
| Contact: Site 0067 | |
| Local Institution | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Site 0040 | |
| Local Institution | Recruiting |
| Erlangen, Germany, 91054 | |
| Contact: Site 0065 | |
| Local Institution | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Site 0066 | |
| Local Institution | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Site 0037 | |
| Local Institution | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Site 0062 | |
| 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 | Recruiting |
| Luebeck, Germany, 23538 | |
| Contact: Site 0051 | |
| Local Institution | Recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Site 0043 | |
| Local Institution | Not yet recruiting |
| Muenster, Germany, 48147 | |
| Contact: Site 0059 | |
| Local Institution | Recruiting |
| Regensburg, Germany, 93053 | |
| Contact: Site 0029 | |
| Local Institution | Recruiting |
| Wurzburg, Germany, 97080 | |
| Contact: Site 0045 | |
| Netherlands | |
| Local Institution | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Site 0030 | |
| Local Institution | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| 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 | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Site 0064 | |
| Norway | |
| Local Institution | Recruiting |
| Oslo, Norway, 0372 | |
| Contact: Site 0039 | |
| Sweden | |
| Local Institution | Recruiting |
| Goteborg, Sweden, 41345 | |
| Contact: Site 0049 | |
| Local Institution | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Site 0063 | |
| Local Institution | Recruiting |
| Uppsala, Sweden, 75185 | |
| Contact: Site 0028 | |
| 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 |
| Zurich, Switzerland, 8006 | |
| Contact: Site 0032 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01820572 History of Changes |
| Other Study ID Numbers: | IM103-116, 2012-001314-42 |
| Study First Received: | March 14, 2013 |
| Last Updated: | February 19, 2015 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
ClinicalTrials.gov processed this record on March 03, 2015