Clinical trial NCT00455013: A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
Official title: A Randomized, Open-Label, Multicenter, Parallel-Group Study of Belatacept (BMS-224818)-Based Corticosteroid-Free Regimens in Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disorder Related to Renal Transplantation
Keywords: Kidney transplant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant


Eligibility criteria: Inclusion Criteria:

* Living or deceased donor renal allograft
* Men and women, 18 to 70 years old
* Subjects who have received a de novo kidney transplant, who have completed the initial study treatment through Month 12, and are willing to sign informed consent will be eligible to continue into the long term extension phase

Exclusion Criteria:

* Pregnant or breastfeeding women
* Epstein Barr Virus (EBV) negative serology
* First time renal transplant with panel reactive antibody (PRA) ≥ 50% or retransplantation with PRA \> 30%
* Graft loss due to AR
* Positive T-cell or B-cell crossmatch
* Recipients/donors with HIV or hepatitis B/C
* Active tuberculosis (TB)
* Immunosuppressive therapy within 1 year of enrollment
* UNOS ECD organs will be excluded
* Body mass index (BMI) \> 35 kg/m²
* Subjects who have developed any malignancy (other than non-melanoma skin cancer) or other medical condition that, in the investigator's opinion, should not be treated with an experimental immunosuppressive drug like belatacept

Primary outcomes:
measure: Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population
timeFrame: Day 1 to Month 6 post-transplantation
Secondary outcomes:
measure: Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population
timeFrame: Day 1 to Month 12 post transplantation
measure: Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population
timeFrame: Day 1 to Month 6 and Month 12 post transplantation
measure: Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population
timeFrame: Day 1 up to Month 6
measure: Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population
timeFrame: Day 1 up to Month 12
measure: Number of Participants With Delayed Graft Function - Intent to Treat Population
timeFrame: From Day 1 up to and including Day 8 post transplantation
measure: Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population
timeFrame: Baseline to Month 12
measure: Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population
timeFrame: Baseline and Month 12
measure: Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population
timeFrame: Baseline and 12 months post transplantation
measure: Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population
timeFrame: Month 12
measure: Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population
timeFrame: Baseline to Month 12
measure: Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population
timeFrame: Months 3, 6 and 12 post transplantation
measure: Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population
timeFrame: Day 1 through Month 12
measure: Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population
timeFrame: Day 1 to Month 12 post transplantation
measure: Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension
timeFrame: End of Month 12 to end of Month 48 Post Transplantation
measure: Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension
timeFrame: End of Month 12 to end of Long Term Extension (Year 4)
measure: Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension
timeFrame: Months 24, 36 and 48 post transplantation
measure: Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension
timeFrame: End of Month 12 to end of Long Term Extension (Year 4)
measure: Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension
timeFrame: Months 24, 36, 48
measure: Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion
timeFrame: End of Month 12 to end of Study (Month 48)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf
state: California
city: Denver
country: United States
facility: Denver Nephrology, Pc
state: Colorado
city: Denver
country: United States
facility: University Of Colorado Health Sciences Center
state: Colorado
city: Augusta
country: United States
facility: Medical College Of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Detriot
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University Of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Bologna
country: Italy
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: