Trial · NCT07038382
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
NCT07038382, Phase 2, Recruiting, Shanghai Henlius Biotech
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis. Trials, record NCT07038382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07038382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
- NCT number
- NCT07038382
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Membranous Nephropathy, Lupus Nephritis (LN)
- Interventions
- HLX79 10mg/kg/Placebo+HLX01, HLX79 20mg/kg/Placebo + HLX01, HLX79 30mg/kg/placebo+HLX01
- First posted
- 2025-06-26
- Last updated
- 2025-11-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 24 weeks | Including incidence, nature, and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, and the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), abnormal laboratory tests, vital signs, physical examination, and 12-lead ECG |
| Secondary | Assessment of safety | 52 weeks | Safety: Proportion of subjects with at least one Grade 3 or greater infection-related AE in each dose group according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, and higher grades mean a worse outcome. |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Peak concentration (Cmax, Cmax, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Time to peak (Tmax, Tmax, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Area under the concentration-time curve (AUC0-inf, AUC0-t, AUC0-tau, AUCss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Elimination half-life (t1/2, t1/2, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Clearance (CL, CLss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Volume of distribution (Vz, Vss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Accumulation ratio (Rac) |
| Secondary | PD | 52 weeks | Proportion of subjects with peripheral blood CD19+ B lymphocyte count ≤ 5/μL at weeks 12, 24, 36, and 52 of treatment, and proportion of subjects with peripheral blood CD20+ B lymphocyte count ≤ 1/μL at weeks 12, 24, 36, and 52 of treatment |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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/NCT07038382
GET https://conductscience.org/api/trials/v1/NCT07038382/registered