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

February 22, 2016 updated by: EMD Serono

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, 128 50, Czech Republic
        • Institute of Rheumatology
  • Malaysia
      • Kedah, Malaysia
        • Hospital Sultanah Bahiyah
      • Kuala Lumpur, Malaysia
        • University of Malaya Medical Centre
      • Kuala Lumpur, Malaysia
        • Hospital University Kebangsaan Malaysia
      • Pulau Pinang, Malaysia
        • Hospital Pulau Pinang
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • Changi General Hospital
  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
  • United States
    • Louisiana
      • New Orleans,, Louisiana, United States
        • Tulane University Hospital and Clinic Department of Internal Medicine
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology Research
    • Michigan
      • Detroit, Michigan, United States
        • Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
    • New York
      • Manhasset, New York, United States, 11030
        • The Feinstein Institute for Medical Research
      • New York, New York, United States, 10003
        • Seligman Center for Advanced Therapeutics
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University Health Sciences
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati College of Medicine
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest Rheumatology and Research Group, LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • 1711 St. Julian Place
      • Orangeburg, South Carolina, United States, 29118
        • Acme Research, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
Drug: Atacicept
Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
Drug: Mycophenolate mofetil
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Drug: Corticosteroids
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Placebo Comparator: Placebo Plus Mycophenolate mofetil Plus Corticosteroids
Drug: Mycophenolate mofetil
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Drug: Corticosteroids
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Drug: Placebo
Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
Time Frame: At Week 52
Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Normalization of Renal Function
Time Frame: At Week 52
At Week 52
Number of Participants With New Lupus Flares
Time Frame: At Week 52
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

ZymoGenetics

Investigators

  • Study Director: Medical Responsible, EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28113
  • 493G01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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