Trial · NCT03955445
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
NCT03955445, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN. Trials, record NCT03955445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03955445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
- NCT number
- NCT03955445
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 225 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis
- Interventions
- LNP023
- First posted
- 2019-05-20
- Last updated
- 2026-08-07
- Other registries' IDs
- eudract:2018-004253-24
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint | 9-month visit | A participant meets the requirements of the composite renal endpoint if they satisfy the following criteria at the 9-month visit in CLNP023B12001B: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to \<300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL (i.e., ≥ the lower limit of normal (LLN)). Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as not meeting the endpoint. |
| Primary | CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score | 6 - to 9- month visit | Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study. |
| Primary | Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Number of participants with AEs of special interest will be collected to evaluate the long-term safety and tolerability of iptacopan in participants. |
| Primary | Number of participants with study drug discontinuation due to an AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Number of participants with study drug discontinuation due to an AE to evaluate the long-term safety and tolerability of iptacopan in participants. |
| Primary | Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Number of participants with abnormal clinically significant vital signs, ECGs, and safety laboratory measurements to evaluate the long-term safety and tolerability of iptacopan in participants. |
| Secondary | CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint | 9-month visit | A participant is defined as achieving the composite renal endpoint if they meet the following criteria at the 9-month visit in CLNP023B12001B: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to \<300 mg/g in UPCR. Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as a not meeting the composite renal endpoint. |
| Secondary | CLNP023X2202: Change from baseline in log-transformed urine protein/creatinine ratio (UPCR) | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Long-term effect of LNP023 on renal function in C3G subjects by assessing the change from baseline in log-transformed urine protein/creatinine ratio (UPCR) |
| Secondary | CLNP023X2202: Change from baseline in log-transformed urine albumin/creatinine ratio (UACR) | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Long-term effect of LNP023 on renal function in C3G subjects by assessing the change from baseline in log-transformed urine albumin/creatinine ratio (UACR) |
| Secondary | CLNP023X2202: Change from baseline in serum creatinine concentration | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Long-term effect of LNP023 on renal function in C3G subjects by assessing the change in serum creatinine compared to CLNP023X2202 baseline |
| Secondary | CLNP023X2202: Change from baseline in estimated glomerular filtration rate (eGFR) | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Long-term effect of LNP023 on renal function in C3G subjects by assessing the change in eGFR compared to CLNP023X2202 baseline |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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/NCT03955445
GET https://conductscience.org/api/trials/v1/NCT03955445/registered