Clinical trial NCT00402168: A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Official title: Belatacept Conversion Trial in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied


Eligibility criteria: Key Inclusion Criteria:

* Men and women age 18 and older
* 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
* calculated GFR ≥35 and ≤75mL/min/1.73 m²
* subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)

Key Exclusion Criteria:

* Significant infection
* acute rejection within 3 months
* prior graft loss due to rejection
* pregnancy
* positive crossmatch

Primary outcomes:
measure: Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)
timeFrame: Baseline to 12 months post randomization
Secondary outcomes:
measure: Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)
timeFrame: Baseline to 6 months post randomization
measure: Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants
timeFrame: At 6 and 12 months post randomization
measure: Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization
timeFrame: At 6 and 12 months post randomization
measure: Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants
timeFrame: Month 12
measure: Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12
timeFrame: 12 Months post randomization
measure: Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants
timeFrame: Month 12 post randomization
measure: Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies
timeFrame: Month 6 and Month 12 Post Randomization
measure: Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants
timeFrame: Baseline to Month 6 and Month 12 Post Randomization
measure: Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12
timeFrame: First Dose (Day 1) to Month 12
measure: Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants
timeFrame: Baseline, Month 12
measure: Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants
timeFrame: Baseline (screening) to Month 12
measure: Ridit Score at Month 12 - All Randomized Participants
timeFrame: Month 12
measure: Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants
timeFrame: Baseline up to Month 12
measure: Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period
timeFrame: Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
measure: Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period
timeFrame: Post Month 12 up to Year 6 of the Study
measure: Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period
timeFrame: Post Months 24, 36, 48, up to Year 6 of the Study
measure: Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period
timeFrame: Baseline (screening) up to Month 36 post randomization
measure: Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period
timeFrame: First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study
measure: Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period
timeFrame: First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study
measure: Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period
timeFrame: Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
measure: Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period
timeFrame: Baseline (Screening), up to Year 6 of the Study
measure: Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure
timeFrame: Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
measure: Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure
timeFrame: Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
measure: Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch
timeFrame: Day of Switch (first belatacept dose) to Week 96 Post Switch
measure: Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs
timeFrame: Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Los Angeles
country: United States
facility: National Institute Of Transplantation
state: California
city: San Diego
country: United States
facility: California Institute Of Renal Research
state: California
city: San Francisco
country: United States
facility: Ucsf
state: California
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Kenner
country: United States
facility: Pharmacy, First Call Iv
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: Chapel Hill
country: United States
facility: University Of North Carolina School Of Medicine
state: North Carolina
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Bruxelles
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Bonsucesso
country: Brazil
facility: Local Institution
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rs
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Paris
country: France
facility: Local Institution
state: Cedex 15
city: Toulouse
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Charite Berlin Mitte
city: Homburg/saar
country: Germany
facility: Local Institution
city: Paladi
country: India
facility: Local Institution
state: Ahmedabad
city: Nadiad
country: India
facility: Local Institution
state: Gujarat
city: Kochi
country: India
facility: Local Institution
state: Kerala
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: San Luis Potosi
country: Mexico
facility: Local Institution
state: Snl
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Tlalpan, C P
country: Mexico
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyo J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.