Lupus NephritisPhase 2/3NCT00573157
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
A Phase 2/3 study testing Atacicept, Mycophenolate mofetil and Corticosteroids in people with Lupus Nephritis, run by EMD Serono at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Atacicept, Mycophenolate mofetil and Corticosteroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Dec 2007to Apr 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States12 sites
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
Beachwood, Ohio, 44122
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
1711 St. Julian Place
Columbia, South Carolina, 29204
The Ohio State University Medical Center
Columbus, Ohio, 43210
Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
Detroit, Michigan
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, 44130
Tulane University Hospital and Clinic Department of Internal Medicine
New Orleans, Louisiana
Seligman Center for Advanced Therapeutics
New York, New York, 10003
ACME Research, LLC
Orangeburg, South Carolina, 29118
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109
Malaysia4 sites
Hospital Sultanah Bahiyah
Kedah
Hospital University Kebangsaan Malaysia
Kuala Lumpur
University of Malaya Medical Centre
Kuala Lumpur
Hospital Pulau Pinang
Pulau Pinang
Singapore2 sites
Changi General Hospital
Singapore
Singapore General Hospital
Singapore
About this study
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.
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.
- Conditions
- Lupus Nephritis
- Being tested
- Atacicept, Mycophenolate mofetil, Placebo, Corticosteroids
- Keywords
- nephritis, atacicept
- Medical subject headings
- Lupus Nephritis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
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.
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.
PlaceboDrug
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.
CorticosteroidsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Atacicept Plus Mycophenolate mofetil Plus Corticosteroids | Experimental | Not described Receives: Drug: Atacicept; Drug: Mycophenolate mofetil; Drug: Corticosteroids |
| Placebo Plus Mycophenolate mofetil Plus Corticosteroids | Placebo comparator | Not described Receives: Drug: Mycophenolate mofetil; Drug: Placebo; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 52
Secondary outcomes (2)
Percentage of Participants With Normalization of Renal Function
Measured: At Week 52
Number of Participants With New Lupus Flares
Measured: At Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: The study was terminated due to unanticipated safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ZymoGenetics
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573157
- Sponsor's protocol ID
- 28113
- Other IDs
- 493G01
- Status last verified
- Feb 2016
- First submitted
- 11 Dec 2007
- Last updated
- 23 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22325903
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00573157
- Acronym / sponsor ID
- 28113
- Conditions
- Lupus Nephritis
- Keywords
- nephritis, atacicept
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to unanticipated safety issues
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- ZymoGenetics
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 23 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atacicept Plus Mycophenolate mofetil Plus Corticosteroids | Experimental | Drug: Atacicept, Drug: Mycophenolate mofetil, Drug: Corticosteroids |
| Placebo Plus Mycophenolate mofetil Plus Corticosteroids | Placebo comparator | Drug: Mycophenolate mofetil, Drug: Placebo, Drug: Corticosteroids |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciceptAtacicept 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 | Atacicept Plus Mycophenolate mofetil Plus Corticosteroids |
| Mycophenolate mofetilMMF 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 | Atacicept Plus Mycophenolate mofetil Plus Corticosteroids, Placebo Plus Mycophenolate mofetil Plus Corticosteroids |
| PlaceboPlacebo 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. | Drug | Placebo Plus Mycophenolate mofetil Plus Corticosteroids |
| CorticosteroidsHigh 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 | Atacicept Plus Mycophenolate mofetil Plus Corticosteroids, Placebo Plus Mycophenolate mofetil Plus Corticosteroids |
Primary outcome
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.
2 secondary outcomes
Percentage of Participants With Normalization of Renal Function
Time frame: At Week 52
Number of Participants With New Lupus Flares
Time frame: At Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22325903Ginzler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atacicept, Mycophenolate mofetil and Corticosteroids in people with Lupus Nephritis, run by EMD Serono at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Malaysia, Singapore, Czechia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00573157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.