Terminated
PHASE2, PHASE3
INTERVENTIONAL
NCT00430677
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.
Detailed Description
Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study
Interventions
Name:
Corticosteroids (prednisone or prednisolone)
Type:
DRUG
Description:
tablets, oral, 0.5-0.8 mg/kg, daily
Name:
Abatacept
Type:
DRUG
Description:
intravenous solution, injectable, 30 mg/kg, every 28 days
Name:
Abatacept
Type:
DRUG
Description:
intravenous solution, injectable, 10 mg/kg, every 28 days
Name:
Mycophenolate mofetil (MMF)
Type:
DRUG
Description:
tablets, oral, 1.5 to 2 g, daily
Name:
Abatacept
Type:
DRUG
Description:
intravenous solution, injectable, 10 mg/kg, every 28 days
Primary Outcomes
Measure:
Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
TimeFrame:
Day 1 (randomization) to 12 months.
Description:
Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate \[GFR\] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio \<30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.
Trial Information
NCT ID
NCT00430677
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2, PHASE3
Sponsor
Bristol-Myers Squibb
Last Updated
December 15, 2025