Trial · NCT03832114
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
NCT03832114, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2022-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted. Trials, record NCT03832114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03832114
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
- NCT number
- NCT03832114
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Glomerulonephritis
- Interventions
- LNP023
- First posted
- 2019-02-06
- Last updated
- 2024-01-30
- Results first posted
- 2022-07-08
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) | Week 12 | Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection |
| Primary | Cohort B: Change From Baseline in C3 Deposit | Week 12 | Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy) |
| Secondary | Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Week 12: Day 84 | Ratio to baseline UPCR derived from 24 hour urine collection |
| Secondary | Change From Baseline in Urine Protein (UP) Excretion | Week 12: Day 84 | Ratio to baseline UP excretion derived from 24 hour urine collection |
| Secondary | Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Week 12: Day 84 | Ratio to baseline UACR excretion derived from 24 hour urine collection |
| Secondary | Change From Baseline Change in Urinary Albumin (UA) Excretion | Week 12: Day 84 | Ratio to baseline UA excretion derived from 24 hour urine collection |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Day 84 | Effect of LNP023 on estimated glomerular filtration rate (eGFR) |
| Secondary | Change From Baseline in Serum Creatinine | Week 12: Day 84 | The effect of LNP023 on renal function - serum creatinine |
| Secondary | Change From Baseline in Creatinine Clearance | Week 12: Day 84 | The effect of LNP023 on renal function - creatinine clearance |
| Secondary | Number of Patients With Hematuria | Week 12: Day 84 | The effect of LNP023 on renal function - hematuria |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) | Week 12 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ratio | GEOMETRIC_MEAN |
| PRIMARY | Cohort B: Change From Baseline in C3 Deposit | Week 12 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Percentage change | MEDIAN |
| SECONDARY | Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Urine Protein (UP) Excretion | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline Change in Urinary Albumin (UA) Excretion | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | ml/min | MEAN |
| SECONDARY | Change From Baseline in Serum Creatinine | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Creatinine Clearance | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | mL/min | GEOMETRIC_MEAN |
| SECONDARY | Number of Patients With Hematuria | Week 12: Day 84 | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable. n: number of patients in the respective baseline category and post-baseline time point. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) | Cohort A - no Kidney Transplant | 0.55 | 80% Confidence Interval 0.46 to 0.65 | ratio | |
| Cohort B: Change From Baseline in C3 Deposit | Cohort B - Kidney Transplant | -2.50 | 80% Confidence Interval -3.75 to -0.75 | Percentage change | |
| Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Cohort A - no Kidney Transplant | 0.55 | 80% Confidence Interval 0.46 to 0.65 | ratio | |
| Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Cohort B - Kidney Transplant | 0.79 | 80% Confidence Interval 0.49 to 1.28 | ratio | |
| Change From Baseline in Urine Protein (UP) Excretion | Cohort A - no Kidney Transplant | 0.57 | 80% Confidence Interval 0.47 to 0.68 | ratio | |
| Change From Baseline in Urine Protein (UP) Excretion | Cohort B - Kidney Transplant | 1.00 | 80% Confidence Interval 0.75 to 1.33 | ratio | |
| Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Cohort A - no Kidney Transplant | 0.55 | 80% Confidence Interval 0.47 to 0.64 | ratio | |
| Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Cohort B - Kidney Transplant | 0.61 | 80% Confidence Interval 0.30 to 1.27 | ratio | |
| Change From Baseline Change in Urinary Albumin (UA) Excretion | Cohort A - no Kidney Transplant | 0.57 | 80% Confidence Interval 0.47 to 0.70 | ratio | |
| Change From Baseline Change in Urinary Albumin (UA) Excretion | Cohort B - Kidney Transplant | 0.81 | 80% Confidence Interval 0.67 to 0.98 | ratio |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Phase | STARTED | Cohort A: Run-In Phase | 16 | |
| Run-in Phase | STARTED | Cohort B: Run-In Phase | 11 | |
| Run-in Phase | STARTED | Cohort A: Dose Escalation/LNP023 Treatment 200 mg b.i.d | 0 | |
| Run-in Phase | STARTED | Cohort B - Dose Escalation/LNP023 Treatment 200 mg b.i.d | 0 | |
| Run-in Phase | COMPLETED | Cohort A: Run-In Phase | 16 | |
| Run-in Phase | COMPLETED | Cohort B: Run-In Phase | 11 | |
| Run-in Phase | COMPLETED | Cohort A: Dose Escalation/LNP023 Treatment 200 mg b.i.d | 0 | |
| Run-in Phase | COMPLETED | Cohort B - Dose Escalation/LNP023 Treatment 200 mg b.i.d | 0 | |
| Run-in Phase | NOT COMPLETED | Cohort A: Run-In Phase | 0 | |
| Run-in Phase | NOT COMPLETED | Cohort B: Run-In Phase | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events252
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 | Cohort A - Run-in Phase | 0 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A - Dose Escalation Phase | 1 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A - LNP023 200mg b.i.d | 0 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B - Run-in Phase | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B - Dose Escalation Phase | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B - LNP023 200mg b.i.d | 0 | 11 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Cohort A - Run-in Phase | 0 | 16 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Cohort A - Dose Escalation Phase | 0 | 16 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Cohort A - LNP023 200mg b.i.d | 1 | 16 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Cohort B - Run-in Phase | 0 | 11 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A - Run-in Phase | 0 | 16 |
| Total, all-cause mortality | Cohort A - Dose Escalation Phase | 0 | 16 |
| Total, all-cause mortality | Cohort A - LNP023 200mg b.i.d | 0 | 16 |
| Total, all-cause mortality | Cohort B - Run-in Phase | 0 | 11 |
| Total, all-cause mortality | Cohort B - Dose Escalation Phase | 0 | 11 |
| Total, all-cause mortality | Cohort B - LNP023 200mg b.i.d | 0 | 11 |
| Total, other adverse events | Cohort A - Run-in Phase | 0 | 16 |
| Total, other adverse events | Cohort A - Dose Escalation Phase | 6 | 16 |
| Total, other adverse events | Cohort A - LNP023 200mg b.i.d | 8 | 16 |
| Total, other adverse events | Cohort B - Run-in Phase | 0 | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38106570 | 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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03832114
GET https://conductscience.org/api/trials/v1/NCT03832114/results?page=2