Trial · NCT00573157
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
NCT00573157, Phase 2, Phase 3, Terminated, EMD Serono; results first posted 2016-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis. Trials, record NCT00573157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573157
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
- NCT number
- NCT00573157
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 6 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Lupus Nephritis
- Interventions
- Atacicept, Mycophenolate mofetil, Placebo, Corticosteroids
- First posted
- 2007-12-14
- Last updated
- 2016-03-23
- Results first posted
- 2016-03-23
- Limitations and caveats
- The study was terminated due to unanticipated safety issues.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response | 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. |
| Secondary | Percentage of Participants With Normalization of Renal Function | At Week 52 | |
| Secondary | Number of Participants With New Lupus Flares | At Week 52 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response | At Week 52 | Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed. | ||
| SECONDARY | Percentage of Participants With Normalization of Renal Function | At Week 52 | Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed. | ||
| SECONDARY | Number of Participants With New Lupus Flares | At Week 52 | Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 4 | |
| Overall Study | STARTED | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 2 | |
| Overall Study | COMPLETED | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | |
| Overall Study | COMPLETED | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | |
| Overall Study | NOT COMPLETED | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 4 | |
| Overall Study | NOT COMPLETED | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 2 |
Source ClinicalTrials.gov
Adverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 4 | |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | 2 | |
| other | Rectal haemorrhage | Gastrointestinal disorders | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 4 | |
| other | Rectal haemorrhage | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | 2 | |
| other | Vomiting | Gastrointestinal disorders | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 4 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | 2 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | ||
| Total, all-cause mortality | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | ||
| Total, other adverse events | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 4 | 4 |
| Total, other adverse events | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 1 | 2 |
| Total, serious adverse events | Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids | 3 | 4 |
| Total, serious adverse events | Placebo Plus Mycophenolate Mofetil Plus Corticosteroids | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22325903 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids vs Placebo Plus Mycophenolate Mofetil Plus Corticosteroids: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00573157
GET https://conductscience.org/api/trials/v1/NCT00573157/events?page=2