Clinical trial NCT01820572: A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Official title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Survive With a Functional Graft at 24 Months
timeFrame: at 24 Months
Secondary outcomes:
measure: Percentage of Participants Who Survive With a Functional Graft at 12 Months
timeFrame: at 12 Months
measure: Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
timeFrame: at 12 and 24 Months
measure: Number of Participants With Varying Severity of BPAR
timeFrame: at 12 and 24 months
measure: Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
timeFrame: at 12 and 24 months
measure: Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
timeFrame: at 12 and 24 months
measure: Mean Calculated Glomerular Filtration Rate (cGFR)
timeFrame: up to 24 months
measure: Slope Analysis of cGFR
timeFrame: at 12 and 24 Months
measure: Slope Analysis of 1/Serum Creatinine
timeFrame: at 12 and 24 Months
measure: Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
timeFrame: at 12 and 24 Months
measure: Mean Urine Protein/ Creatinine Ratio (UPCR)
timeFrame: Up to 24 Months
measure: Mean Change From Baseline in Systolic and Diastolic Blood Pressure
timeFrame: at 12 and 24 months
measure: Number of Antihypertensive Medications Used to Control Hypertension
timeFrame: at baseline, 12 and 24 Months
measure: Number of Participants With Donor Specific Antibodies (DSA)
timeFrame: at baseline, 12 and 24 months
measure: Mean Number of Symptom Occurrence and Symptom Distress
timeFrame: up to 12 Months
measure: Number of Participants With an Adverse Event of Special Interest
timeFrame: 24 Months
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: 24 Months
measure: Mean Change From Baseline in Vital Signs: Heart Rate
timeFrame: at 12 and 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Division of Nephrology
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Kidney Transplant Research Office
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC (PI Address)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Transplant Research Institute (PI Address)
state: California
city: Sacramento
country: United States
facility: University of California, San Francisco (UCSF)-Kidney Transplant Service
state: California
city: San Diego
country: United States
facility: California Institute Of Renal Research
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center, Depart of Transplantation (PI Address)
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver (PI Address)
state: Colorado
city: Denver
country: United States
facility: Denver Nephrologists, PC
state: Colorado
city: New Haven
country: United States
facility: Yale Medical Group
state: Connecticut
city: Orlando
country: United States
facility: Florida Hospital Transplant Institute (PI Address)
state: Florida
city: Saint Petersburg
country: United States
facility: Central Pharmacy
state: Florida
city: Tampa
country: United States
facility: Tampa General Medicine Group
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia at Augusta University
state: Georgia
city: Chicago
country: United States
facility: RUSH University Transplant Program (PI Address)
state: Illinois
city: Chicago
country: United States
facility: University of Wisconsin School of Medicine and Public Health (PI Address)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Health Care (PI Address)
state: Iowa
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Portland
country: United States
facility: Maine Transplant Program
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford's Transplant Institute
state: Michigan
city: Roseville
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington Univ School of Med
state: Missouri
city: Omaha
country: United States
facility: University or Nebraska Medical Center
state: Nebraska
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Recanati/Miller Transplantation Institue (PI Address)
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center (PI Address)
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Univ Nephrology Clin Res. Lab
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Harrisburg
country: United States
facility: Central PA Transplant Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina, SCTR Research Nexus
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital Transplant Institute (PI Address)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center- GI Research Office
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Ft. Worth
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Depart of Nephrology (PI Address)
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System (PI Address)
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center (PI Address & Study Supplies Address)
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Childrens Hospital
state: Washington
city: Milwaukee
country: United States
facility: Medical College of WI Froedtert Hospital
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mendoza
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Cardoba
country: Argentina
facility: Local Institution
state: Cordoba
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Feldkirch
country: Austria
facility: Local Institution
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Cali
country: Colombia
facility: Local Institution
state: Valle DEL Cauca
city: Bogota
country: Colombia
facility: Local Institution
city: Paris
country: France
facility: Local Institution
state: Cedex 15
city: Bois-Guillaume
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Brest Cedex 2
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: GRENOBLE Cedex 09
country: France
facility: Local Institution
city: Le Kremilin Bicretre
country: France
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 8
country: France
facility: CHU Rangueil
city: Berlin
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt am Main
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Lubeck
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Munster
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Wurzburg
country: Germany
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Toensberg Norge
country: Norway
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Bern
country: Switzerland
facility: Local Institution
city: Geneve 14
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: