Trial · NCT03373461
Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation
NCT03373461, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2022-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation. Trials, record NCT03373461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03373461
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation
- NCT number
- NCT03373461
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- IgA Nephropathy
- Interventions
- LNP023, Placebo
- First posted
- 2017-12-14
- Last updated
- 2023-01-30
- Other registries' IDs
- eudract:2017-000891-27
- Results first posted
- 2022-10-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | Baseline and Day 90 | The primary analysis of the dose-response effect of LNP023 versus placebo on the reduction in UPCR 24 hours at Day 90 was done using Multiple Comparison Procedure Modelling (MCP-Mod). The existence of a dose-response relationship was assessed at the MCP step at the one-sided 10% significance level vis a multiple contrasts test. In the Mod step, the mean predicted difference between each LNP023 dose and placebo were then estimated using parametric bootstrap model averaging. Results are presented on the original scale as geometric mean ratios. A ratio less than 1 indicates a reduction in proteinuria. Participants collected all urine over a 24 hour period for UPCR test. |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | Baseline and Day 90 | eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). The CKD-EPI equation is an established, widely used and Kidney Disease Improving Global Outcomes (KDIGO) guideline recommended method of GFR estimation based on serum creatinine, age, gender and race of the patient. It was derived and validated established from a meta-analyses of multiple studies including large number of patients. |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Serum Creatinine - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Serum creatinine |
| Secondary | Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 90 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24hour Urine Protein (UP) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Participants collected all of their urine over a 24-hour period. |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline of 24 Hour Urine Albumin (UA) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Participants collected all of their urine over a 24-hour period. |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Participants collected all of their urine over a 24-hour period. |
| Secondary | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in Urine Protein to Creatinine (UPCR) From 1st Morning Void - Parts 1 and 2 at Day 90 | Baseline and Day 90 | A midstream urine sample was obtained from the first morning void (FMV) on the visit day. |
| Secondary | Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) at Day 30 | Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs) | AUClast,ss: the area under the plasma concentration-time curve from time zero to last quantifiable concentration at steady state AUCtau,ss: the area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state |
| Secondary | Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) and Maximum Concentrations (Cmax,ss) at Day 30 | Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs) | Cmax,ss: the observed maximum plasma concentration following drug administration at steady state (ng/mL) Ctrough,ss: the pre-dose plasma concentration observed during a dosing interval at steady state (ng/mL) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | Ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | mL/min/SSA | MEAN |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Serum Creatinine - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | umol/L | MEAN |
| SECONDARY | Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with both baseline and Day 90 hematuria values. The number of participants analyzed corresponds to the column totals (i.e. the number of patients with non-missing baseline and day 90 values by hematuria level at Day 90 and treatment group). | participants | NUMBER |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24hour Urine Protein (UP) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | Ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline of 24 Hour Urine Albumin (UA) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | Ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Parts 1 and 2 to Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | Ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in Urine Protein to Creatinine (UPCR) From 1st Morning Void - Parts 1 and 2 at Day 90 | Baseline and Day 90 | Full analysis set - all randomized patients with a baseline and at least one post-baseline value | Ratio to baseline | GEOMETRIC_MEAN |
| SECONDARY | Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) at Day 30 | Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs) | PK analyses set - number of participants with evaluable results for each parameter | hr*ng/mL | MEAN |
| SECONDARY | Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) and Maximum Concentrations (Cmax,ss) at Day 30 | Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs) | PK analyses set - number of participants with evaluable results for each parameter | ng/mL | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group199
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | LNP023 10 mg BID | 0.85 | 80% Confidence Interval 0.77 to 0.93 | Ratio to baseline | |
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | LNP023 50 mg BID | 0.80 | 80% Confidence Interval 0.73 to 0.87 | Ratio to baseline | |
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | LNP023 100 mg BID - Part 2 | 0.76 | 80% Confidence Interval 0.70 to 0.81 | Ratio to baseline | |
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | LNP023 200 mg BID | 0.69 | 80% Confidence Interval 0.61 to 0.77 | Ratio to baseline | |
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | Placebo | 0.88 | 80% Confidence Interval 0.80 to 1.00 | Ratio to baseline | |
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | LNP023 10 mg BID | -0.06 | Standard Error 1.760 | mL/min/SSA | |
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | LNP023 50 mg BID | 2.49 | Standard Error 1.859 | mL/min/SSA | |
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | LNP023 100 mg BID - Part 2 | 0.23 | Standard Error 1.821 | mL/min/SSA | |
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | LNP023 200 mg BID | 2.42 | Standard Error 1.545 | mL/min/SSA | |
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | Placebo | -3.34 | Standard Error 1.606 | mL/min/SSA |
1 to 10 of 199Source ClinicalTrials.gov
See all 199 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | LNP023 10 mg BID | 9 | |
| Part 1 | STARTED | LNP023 50 mg BID | 8 | |
| Part 1 | STARTED | LNP023 100 mg BID - Part 2 | 0 | |
| Part 1 | STARTED | LNP023 200 mg BID | 15 | |
| Part 1 | STARTED | Placebo | 14 | |
| Part 1 | COMPLETED | LNP023 10 mg BID | 9 | |
| Part 1 | COMPLETED | LNP023 50 mg BID | 8 | |
| Part 1 | COMPLETED | LNP023 100 mg BID - Part 2 | 0 | |
| Part 1 | COMPLETED | LNP023 200 mg BID | 15 | |
| Part 1 | COMPLETED | Placebo | 14 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,520
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 | Anaemia | Blood and lymphatic system disorders | LNP023 10mg On-treatment | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 50mg On-treatment | 1 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 100mg On-treatment | 0 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 200mg On-treatment | 0 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo On-treatment | 1 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 10mg Follow-up | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 50mg Follow-up | 0 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 100mg Follow-up | 0 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | LNP023 200mg Follow-up | 0 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Follow-up | 0 | 25 |
1 to 10 of 1,520Source ClinicalTrials.gov
See all 1,520 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LNP023 10mg On-treatment | 0 | 20 |
| Total, all-cause mortality | LNP023 50mg On-treatment | 0 | 19 |
| Total, all-cause mortality | LNP023 100mg On-treatment | 0 | 22 |
| Total, all-cause mortality | LNP023 200mg On-treatment | 0 | 26 |
| Total, all-cause mortality | Placebo On-treatment | 0 | 25 |
| Total, all-cause mortality | LNP023 10mg Follow-up | 0 | 20 |
| Total, all-cause mortality | LNP023 50mg Follow-up | 0 | 19 |
| Total, all-cause mortality | LNP023 100mg Follow-up | 0 | 22 |
| Total, all-cause mortality | LNP023 200mg Follow-up | 0 | 26 |
| Total, all-cause mortality | Placebo Follow-up | 0 | 25 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42909451 | DERIVED |
Source PubMed
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.
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