Trial · NCT06406205
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
NCT06406205, Phase 3, Recruiting, Qilu Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis. Trials, record NCT06406205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06406205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
- NCT number
- NCT06406205
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 270 participants, estimated
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Conditions
- Lupus Nephritis
- Interventions
- Voclosporin（QL1074）, Placebo
- First posted
- 2024-05-09
- Last updated
- 2024-05-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Renal Remission at Week 52 | Week 52 | The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20% |
| Secondary | Time to Urine Protein Creatinine Ratio of ≤0.5 g/g(Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 g/g or less. |
| Secondary | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less | 52 Weeks | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less |
| Secondary | Number of Subjects With Partial Renal Response at Week 52 | Week 52 | Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 52. Baseline UPCR is the average of 2 pre-randomisation values. |
| Secondary | Time to 50% Reduction in UPCR (Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values. |
| Secondary | Number of Subjects With Partial Renal Response at Week 24 | Week 24 | Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24. Baseline UPCR is the average of 2 pre-randomisation values. |
| Secondary | Number of Subjects With Renal Response With Low Dose Steroids | Week 24 and Week 52 | Programmed Renal Response whilst on low dose steroids (\<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52 |
| Secondary | Change From Baseline in UPCR | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values. |
| Secondary | Proportion of subjects experiencing a confirmed 30% decrease or more fom baseline in eGFR at each timepoint | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Number of subjects with a 30% or more decrease in estimated glomerular filtration rate compared to baseline at each visit time point that meets diagnostic criteria. |
| Secondary | Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate. | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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/NCT06406205
GET https://conductscience.org/api/trials/v1/NCT06406205/registered