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NCT03385564 · ClinicalTrials.gov registry record · Phase 2
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT03385564: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03385564 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03385564, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
Primary Outcome
The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with complete renal response (CRR) and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either
Interventions
- DRUG Placebo
- DRUG BI 655064
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 2 |
What the finished NCT03385564 record still lists
NCT03385564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03385564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03385564 about?
NCT03385564 is a clinical study titled "An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis". The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
What is the current status of trial NCT03385564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2018-01-09. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT03385564?
The interventions under investigation include: Placebo (DRUG), BI 655064 (DRUG).
Who is sponsoring clinical trial NCT03385564?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03385564's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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