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

Primary Purpose

Lupus Nephritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atacicept
Mycophenolate mofetil
Placebo
Corticosteroids
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring nephritis, atacicept

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tulane University Hospital and Clinic Department of Internal Medicine
  • Northwest Louisiana Nephrology Research
  • Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
  • The Feinstein Institute for Medical Research
  • Seligman Center for Advanced Therapeutics
  • Wake Forest University Health Sciences
  • Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
  • University of Cincinnati College of Medicine
  • The Ohio State University Medical Center
  • Southwest Rheumatology and Research Group, LLC
  • 1711 St. Julian Place
  • ACME Research, LLC
  • Institute of Rheumatology
  • Hospital Sultanah Bahiyah
  • Hospital University Kebangsaan Malaysia
  • University of Malaya Medical Centre
  • Hospital Pulau Pinang
  • Changi General Hospital
  • Singapore General Hospital
  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atacicept Plus Mycophenolate mofetil Plus Corticosteroids

Placebo Plus Mycophenolate mofetil Plus Corticosteroids

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
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.

Secondary Outcome Measures

Percentage of Participants With Normalization of Renal Function
Number of Participants With New Lupus Flares

Full Information

First Posted
December 11, 2007
Last Updated
February 22, 2016
Sponsor
EMD Serono
Collaborators
ZymoGenetics
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1. Study Identification

Unique Protocol Identification Number
NCT00573157
Brief Title
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to unanticipated safety issues
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
Collaborators
ZymoGenetics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
nephritis, atacicept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
Arm Type
Experimental
Arm Title
Placebo Plus Mycophenolate mofetil Plus Corticosteroids
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atacicept
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
Description
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.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Normalization of Renal Function
Time Frame
At Week 52
Title
Number of Participants With New Lupus Flares
Time Frame
At Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Tulane University Hospital and Clinic Department of Internal Medicine
City
New Orleans,
State/Province
Louisiana
Country
United States
Facility Name
Northwest Louisiana Nephrology Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Seligman Center for Advanced Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
Facility Name
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Southwest Rheumatology and Research Group, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
1711 St. Julian Place
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
ACME Research, LLC
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Institute of Rheumatology
City
Prague, 128 50
Country
Czech Republic
Facility Name
Hospital Sultanah Bahiyah
City
Kedah
Country
Malaysia
Facility Name
Hospital University Kebangsaan Malaysia
City
Kuala Lumpur
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
Country
Malaysia
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22325903
Citation
Ginzler EM, Wax S, Rajeswaran A, Copt S, Hillson J, Ramos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012 Feb 7;14(1):R33. doi: 10.1186/ar3738.
Results Reference
derived

Learn more about this trial

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

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