Trial · NCT01369628
Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
NCT01369628, Phase 1, Terminated, EMD Serono
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil. Trials, record NCT01369628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
- NCT number
- NCT01369628
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Lupus Nephritis
- Interventions
- Atacicept
- First posted
- 2011-06-09
- Last updated
- 2013-10-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The nature (preferred terms) and incidence of AEs | 12 weeks | Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen. |
| Primary | Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease | 12 weeks | Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented. |
| Primary | The frequency and severity of laboratory abnormalities | 12 weeks | The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period. |
| Secondary | The nature (preferred terms) and incidence of AEs | 36 weeks | Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen. |
| Secondary | Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease | 36 weeks | Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented. |
| Secondary | The frequency and severity of laboratory abnormalities | 36 weeks | The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01369628
GET https://conductscience.org/api/trials/v1/NCT01369628/registered