Phase 3 N=446 Randomized Treatment

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

Kidney Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT01820572 ↗

Enrolled (actual)

446

Serious AEs

45.6%

Results posted

Jan 2021

Primary outcome: Primary: Percentage of Participants Who Survive With a Functional Graft at 24 Months — 98.2; 97.3 Percentage

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Belatacept (Drug); Tacrolimus (Drug); Cyclosporine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Survive With a Functional Graft at 24 Months	98.2; 97.3	—
SECONDARY Percentage of Participants Who Survive With a Functional Graft at 12 Months	98.7; 99.1	—
SECONDARY Number of Participants With a Biopsy Proven Acute Rejection (BPAR)	18; 4; 18; 9	—
SECONDARY Number of Participants With Varying Severity of BPAR	2; 2; 1; 0; 7; 0	—
SECONDARY Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change	13.2; -0.3; 15.2; 0.3	—
SECONDARY Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change	5.6; -0.7; 6.2; -1.0	—
SECONDARY Mean Calculated Glomerular Filtration Rate (cGFR)	49.8; 49.7; 49.6; 50.7; 53.0; 50.2	—
SECONDARY Slope Analysis of cGFR	0.241; 0.004; 0.281; -0.159; 0.685; -0.112	—
SECONDARY Slope Analysis of 1/Serum Creatinine	0.034; -0.003; 0.033; -0.021; 0.00868; -0.00203	—
SECONDARY Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR	53.4; 28.7; 43.9; 21.5; 54.3; 29.6	—
SECONDARY Mean Urine Protein/ Creatinine Ratio (UPCR)	17.80; 18.61; 22.87; 20.61; 23.42; 20.85	—
SECONDARY Mean Change From Baseline in Systolic and Diastolic Blood Pressure	-1.5; -0.6; -1.7; 0.5; -1.6; 0.1	—
SECONDARY Number of Antihypertensive Medications Used to Control Hypertension	2.1; 2.2; 2.3; 2.2; 2.3; 2.3	—
SECONDARY Number of Participants With Donor Specific Antibodies (DSA)	10; 26; 2; 9; 2; 14	—
SECONDARY Mean Number of Symptom Occurrence and Symptom Distress	87.8; 90.7; 28.7; 34.8; 79.0; 88.6	—
SECONDARY Number of Participants With an Adverse Event of Special Interest	37; 44; 1; 0; 0; 0	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities	0; 0; 0; 0; 0; 1	—
SECONDARY Mean Change From Baseline in Vital Signs: Heart Rate	-1.8; -0.6; -1.9; 1.0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01820572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.