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The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.

NCT00573157•EMD Serono

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of systemic lupus erythematosus (SLE) satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria (Appendix B)
•Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis

Exclusion Criteria

•Estimated glomerular filtration rate (GFR) less than or equal to (\<=) 30 milliliter per minute (mL/min) per 1.73 square meter (m\^2)
•Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment
•Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept.
•Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.

Locations (20)

Tulane University Hospital and Clinic Department of Internal Medicine

New Orleans, Louisiana, United States

Northwest Louisiana Nephrology Research

Shreveport, Louisiana, United States

Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine

Detroit, Michigan, United States

The Feinstein Institute for Medical Research

Manhasset, New York, United States

Seligman Center for Advanced Therapeutics

New York, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center

Beachwood, Ohio, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Southwest Rheumatology and Research Group, LLC

Middleburg Heights, Ohio, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

March 23, 2016

Enrollment

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

Atacicept

DRUG

Mycophenolate mofetil

DRUG

Placebo

DRUG

Corticosteroids

DRUG

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

View study

RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository