Trial · NCT04154787
Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
NCT04154787, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2024-07-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy. Trials, record NCT04154787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04154787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
- NCT number
- NCT04154787
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Idiopathic Membranous Nephropathy
- Interventions
- LNP023, Rituximab
- First posted
- 2019-11-06
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2019-001734-34
- Results first posted
- 2024-07-05
- Limitations and caveats
Per protocol, participants randomized to the former LNP023 low dose arm (LNP023 10/50 mg b.i.d.) were included in the safety and PK analyses but not in the PD/efficacy analyses as the low number of subjects would not have allowed for a meaningful analysis and interpretation of PD/efficacy data.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | Baseline, Day 113, Day 169 | The primary endpoint of this study is the ratio between UPCR at 24 weeks of treatment measured in 24h urine and baseline UPCR . To assess the primary objective, the log-transformed ratio to baseline in UPCR was analyzed using a mixed model for repeated measures (MMRM). The results were back transformed and presented on the original scale. |
| Secondary | Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Baseline, Day 15, Day 29, Day 57, Day 113 and Day 169 | The drug (LNP023) is expected to block the complement alternative pathway dysregulation and thereby should normalize complement biomarker levels in serum. Bb is a biomarker that accurately reflects the level of complement Alternative Pathway activation. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. |
| Secondary | Change From Baseline in Plasma Levels of sC5b-9 | Baseline, Day 15, Day 29, Day 57, Day 113, Day 169 | Soluble C5b-9 (sC5b-9) is a biomarker of the complement pathway activity that correlate with disease progression. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. |
| Secondary | Ratio to Baseline of Urine Protein Creatinine Ratio (UPCR) Measured in First Morning Void | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266 and Day 378 | Adjusted geometric mean ratio to baseline of Urine Protein Creatinine Ratio (UPCR) measured in first morning void. First morning void urine sample was collected in the morning of the day before the visit and kept in the fridge. |
| Secondary | Number of Participants by Treatment Response at 24 Weeks of Treatment | Baseline, Day 169 | Participants were considered complete responders if at 24 weeks of treatment, they showed complete remission of proteinuria (i.e., Urine Protein (UP) ≤ 0.3 g/24h), partial responders if they showed partial remission (i.e., UP \> 0.3g/24h and ≤ 3.5 g/24h and a reduction of UP by \>50% from baseline), and non-responders if UP \>3.5g/24h and/or reduction of UP from baseline \<50%. |
| Secondary | Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | Changes in renal function were assessed via estimated glomerular filtration rate (eGFR). Change in eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. |
| Secondary | Pharmacokinetic Parameter Tmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023 : Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time). Actual sampling time points were considered for the calculation of PK parameters. |
| Secondary | Pharmacokinetic Parameter Cmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023: Cmax is the maximum (peak) observed plasma drug concentration after dose administration (mass x volume-1) |
| Secondary | Pharmacokinetic Parameter AUClast in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023: AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) |
| Secondary | Pharmacokinetic Parameter AUCtau in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023 : AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | Baseline, Day 113, Day 169 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value for UPCR at both Baseline and Day 113 or Day 169 were included in the analysis. | ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Baseline, Day 15, Day 29, Day 57, Day 113 and Day 169 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with values of plasma levels of circulating fragment of factor B at both Baseline and the different time points were included in the analysis. | ng/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Levels of sC5b-9 | Baseline, Day 15, Day 29, Day 57, Day 113, Day 169 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value of plasma levels of sC5b-9 at both Baseline and the different time points were included in the analysis. | ng/mL | MEAN |
| SECONDARY | Ratio to Baseline of Urine Protein Creatinine Ratio (UPCR) Measured in First Morning Void | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266 and Day 378 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value of UPCR measured in first morning void at the different time points were included in the analysis. | ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants by Treatment Response at 24 Weeks of Treatment | Baseline, Day 169 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with UP values at both baseline and Day 169 were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a eGFR value at both Baseline and the different time points were included in the analysis. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Pharmacokinetic Parameter Tmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | hours | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter Cmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter AUClast in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter AUCtau in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | hr*ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | LNP023 200 mg b.i.d. | Day 113 | 0.94 | 95% Confidence Interval 0.74 to 1.20 | ratio to baseline |
| Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | Rituximab | Day 113 | 0.89 | 95% Confidence Interval 0.71 to 1.10 | ratio to baseline |
| Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | LNP023 200 mg b.i.d. | Day 169 | 0.88 | 95% Confidence Interval 0.65 to 1.19 | ratio to baseline |
| Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | Rituximab | Day 169 | 0.64 | 95% Confidence Interval 0.48 to 0.86 | ratio to baseline |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | LNP023 200 mg b.i.d. | Day 15 | 1520.59 | Standard Deviation 9370.086 | ng/mL |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Rituximab | Day 15 | -417.69 | Standard Deviation 701.667 | ng/mL |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | LNP023 200 mg b.i.d. | Day 29 | -732.00 | Standard Deviation 1412.633 | ng/mL |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Rituximab | Day 29 | -318.46 | Standard Deviation 604.440 | ng/mL |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | LNP023 200 mg b.i.d. | Day 57 | -545.00 | Standard Deviation 1379.201 | ng/mL |
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Rituximab | Day 57 | -75.38 | Standard Deviation 787.545 | ng/mL |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LNP023 10/50 mg b.i.d. | 3 | |
| Overall Study | STARTED | LNP023 200 mg b.i.d. | 19 | |
| Overall Study | STARTED | Rituximab | 15 | |
| Overall Study | COMPLETED | LNP023 10/50 mg b.i.d. | 3 | |
| Overall Study | COMPLETED | LNP023 200 mg b.i.d. | 9 | |
| Overall Study | COMPLETED | Rituximab | 14 | |
| Overall Study | NOT COMPLETED | LNP023 10/50 mg b.i.d. | 0 | |
| Overall Study | NOT COMPLETED | LNP023 200 mg b.i.d. | 10 | |
| Overall Study | NOT COMPLETED | Rituximab | 1 |
Source ClinicalTrials.gov
Adverse events280
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 | Lymphopenia | Blood and lymphatic system disorders | LNP023 10/50 mg b.i.d. | 0 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | LNP023 200 mg b.i.d. | 0 | 19 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Pooled LNP023 | 0 | 22 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab | 1 | 15 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Total | 1 | 37 | |
| other | Hypothyroidism | Endocrine disorders | LNP023 10/50 mg b.i.d. | 0 | 3 | |
| other | Hypothyroidism | Endocrine disorders | LNP023 200 mg b.i.d. | 1 | 19 | |
| other | Hypothyroidism | Endocrine disorders | Pooled LNP023 | 1 | 22 | |
| other | Hypothyroidism | Endocrine disorders | Rituximab | 0 | 15 | |
| other | Hypothyroidism | Endocrine disorders | Total | 1 | 37 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LNP023 10/50 mg b.i.d. | 0 | 3 |
| Total, all-cause mortality | LNP023 200 mg b.i.d. | 0 | 19 |
| Total, all-cause mortality | Pooled LNP023 | 0 | 22 |
| Total, all-cause mortality | Rituximab | 0 | 15 |
| Total, all-cause mortality | Total | 0 | 37 |
| Total, other adverse events | LNP023 10/50 mg b.i.d. | 2 | 3 |
| Total, other adverse events | LNP023 200 mg b.i.d. | 13 | 19 |
| Total, other adverse events | Pooled LNP023 | 15 | 22 |
| Total, other adverse events | Rituximab | 7 | 15 |
| Total, other adverse events | Total | 22 | 37 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT04154787
GET https://conductscience.org/api/trials/v1/NCT04154787/results?page=2