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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00402168




Registration number
NCT00402168
Ethics application status
Date submitted
20/11/2006
Date registered
22/11/2006
Date last updated
5/01/2017

Titles & IDs
Public title
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
Scientific title
Belatacept Conversion Trial in Renal Transplantation
Secondary ID [1] 0 0
LEA29Y
Secondary ID [2] 0 0
IM103-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplant 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belatacept
Treatment: Drugs - Cyclosporine A
Treatment: Drugs - Tacrolimus

Experimental: A: Belatacept -

Active comparator: B: calcineurin inhibitor (CNI)-based immunosuppressive regimen -


Treatment: Drugs: Belatacept
IV, IV Infusion, 5 mg/kg once every 28 days for one year

Treatment: Drugs: Cyclosporine A
Tablets, Oral, Trough of 100-250 ng/mL, 2\* daily for one year

Treatment: Drugs: Tacrolimus
Tablets, Oral, Trough of 5-10 ng/mL, 2\* daily for one year
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline to 12 months post randomization
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline to 6 months post randomization
Secondary outcome [2] 0 0
Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants
Timepoint [2] 0 0
At 6 and 12 months post randomization
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
At 6 and 12 months post randomization
Secondary outcome [4] 0 0
Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants
Timepoint [4] 0 0
Month 12
Secondary outcome [5] 0 0
Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12
Timepoint [5] 0 0
12 Months post randomization
Secondary outcome [6] 0 0
Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants
Timepoint [6] 0 0
Month 12 post randomization
Secondary outcome [7] 0 0
Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies
Timepoint [7] 0 0
Month 6 and Month 12 Post Randomization
Secondary outcome [8] 0 0
Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants
Timepoint [8] 0 0
Baseline to Month 6 and Month 12 Post Randomization
Secondary outcome [9] 0 0
Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12
Timepoint [9] 0 0
First Dose (Day 1) to Month 12
Secondary outcome [10] 0 0
Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants
Timepoint [10] 0 0
Baseline, Month 12
Secondary outcome [11] 0 0
Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants
Timepoint [11] 0 0
Baseline (screening) to Month 12
Secondary outcome [12] 0 0
Ridit Score at Month 12 - All Randomized Participants
Timepoint [12] 0 0
Month 12
Secondary outcome [13] 0 0
Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants
Timepoint [13] 0 0
Baseline up to Month 12
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
Secondary outcome [15] 0 0
Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period
Timepoint [15] 0 0
Post Month 12 up to Year 6 of the Study
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Post Months 24, 36, 48, up to Year 6 of the Study
Secondary outcome [17] 0 0
Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period
Timepoint [17] 0 0
Baseline (screening) up to Month 36 post randomization
Secondary outcome [18] 0 0
Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period
Timepoint [18] 0 0
First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study
Secondary outcome [19] 0 0
Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period
Timepoint [19] 0 0
First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study
Secondary outcome [20] 0 0
Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period
Timepoint [20] 0 0
Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
Secondary outcome [21] 0 0
Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period
Timepoint [21] 0 0
Baseline (Screening), up to Year 6 of the Study
Secondary outcome [22] 0 0
Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure
Timepoint [22] 0 0
Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
Secondary outcome [23] 0 0
Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure
Timepoint [23] 0 0
Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
Day of Switch (first belatacept dose) to Week 96 Post Switch
Secondary outcome [25] 0 0
Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs
Timepoint [25] 0 0
Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant infection
* acute rejection within 3 months
* prior graft loss due to rejection
* pregnancy
* positive crossmatch

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Brazil
State/province [12] 0 0
Parana
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio De Janeiro
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
Rs
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Saskatchewan
Country [21] 0 0
France
State/province [21] 0 0
Cedex 15
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Homburg/saar
Country [25] 0 0
India
State/province [25] 0 0
Ahmedabad
Country [26] 0 0
India
State/province [26] 0 0
Gujarat
Country [27] 0 0
India
State/province [27] 0 0
Kerala
Country [28] 0 0
Mexico
State/province [28] 0 0
Distrito Federal
Country [29] 0 0
Mexico
State/province [29] 0 0
Morelos
Country [30] 0 0
Mexico
State/province [30] 0 0
Snl
Country [31] 0 0
Mexico
State/province [31] 0 0
Aguascalientes
Country [32] 0 0
Mexico
State/province [32] 0 0
Tlalpan, C P
Country [33] 0 0
Poland
State/province [33] 0 0
Bydgoszcz
Country [34] 0 0
Poland
State/province [34] 0 0
Szczecin
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00402168
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00402168