Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
ACCESS
A Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept) Plus Cyclophosphamide vs Cyclophosphamide Alone in the Treatment of Lupus Nephritis
1 other identifier
interventional
137
2 countries
23
Brief Summary
This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
October 9, 2014
CompletedFebruary 8, 2016
January 1, 2016
4.1 years
October 16, 2008
August 18, 2014
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Response
Complete response definition: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.
Week 24
Secondary Outcomes (17)
Number of Participants With Partial Response
Week 24
Number of Participants With a Complete or Partial Response
Week 52
Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52
Week 52
Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response
Week 24
Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response
Week 24
- +12 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALAbatacept plus Euro-lupus regimen
Control
PLACEBO COMPARATORAbatacept placebo plus Euro-lupus regimen
Interventions
Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
500 mg intravenous infusion every 2 weeks for 12 weeks
2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24
60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose
Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24
Eligibility Criteria
You may qualify if:
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- Active lupus nephritis (defined by: kidney biopsy documentation within the last 12 months using International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification- proliferative nephritis, active urinary sediment, urine protein-to-creatinine ratio \> 1, low complement C3)
- Positive antinuclear antibody (ANA) test result at time of study entry
You may not qualify if:
- End stage renal disease
- Use of cyclophosphamide in the past year
- Neutropenia, thrombocytopenia, moderately severe anemia
- Active infection, including HIV, hepatitis B or C
- History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
University of California San Diego
La Jolla, California, 92037, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Feinstein Institute
Manhasset, New York, 11030, United States
Seligman Center for Advanced Therapeutics (NYU)
New York, New York, 10003, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Temple University
Philadelphia, Pennsylvania, 19147, United States
University of Pittsburgh Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern
Dallas, Texas, 75390, United States
Unidad de investigación en enfermedades crónico - degenerativas SC
Guadalajara, Jalisco, 44620, Mexico
El Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INNSZ)
Mexico City, Mexico
Related Publications (2)
ACCESS Trial Group. Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study. Arthritis Rheumatol. 2014 Nov;66(11):3096-104. doi: 10.1002/art.38790.
PMID: 25403681RESULTWofsy D, Diamond B, Houssiau FA. Crossing the Atlantic: the Euro-Lupus Nephritis regimen in North America. Arthritis Rheumatol. 2015 May;67(5):1144-6. doi: 10.1002/art.39067. No abstract available.
PMID: 25779381RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
David Wofsy, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Betty Diamond, MD
Feinstein Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2012
Study Completion
June 1, 2014
Last Updated
February 8, 2016
Results First Posted
October 9, 2014
Record last verified: 2016-01