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Immunosuppressant

tacrolimus, MMF for Renal Transplant Disorder

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 24, 36, 48
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 24, 36, 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 24, 36, 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aortic Valve Insufficiency
Secondary outcome measures
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
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
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: tacrolimus, MMFExperimental Treatment3 Interventions
(IMPs as comparator regimen)thymoglobulin 1.5mg/kg for 4 days; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Group II: belatacept, sirolimusExperimental Treatment3 Interventions
thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months;sirolimus 5 mg/day on Day 1 (day of transplant)and continued through Day 2, dosing to be adjusted to keep pre-dose C0 levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until 12 months.
Group III: belatacept, mycophenolate mofetil (MMF)Experimental Treatment3 Interventions
thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF 1g twice daily(bis in die, BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved
Sirolimus
FDA approved
Antithymocyte immunoglobulin (rabbit)
FDA approved
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,656 Total Patients Enrolled
~5 spots leftby Jul 2025
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