Trial · NCT05755386
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
NCT05755386, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN. Trials, record NCT05755386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05755386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
- NCT number
- NCT05755386
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 106 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- IC-MPGN
- Interventions
- Placebo, iptacopan
- First posted
- 2023-03-06
- Last updated
- 2026-07-13
- Other registries' IDs
- eudract:2022-002328-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months. | 6 months (double-blind) | To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months. |
| Primary | Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm) | 18 months | To evaluate the effect of iptacopan on proteinuria at 18 months. |
| Primary | Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm. | 18 months | To evaluate the effect of iptacopan on proteinuria at 18 months. |
| Secondary | Change from baseline in eGFR | 12 months and 18 months | To demonstrate the superiority of iptacopan vs. placebo in improving estimated glomerular filtration rate (eGFR). |
| Secondary | Change in eGFR from the 12-month visit to the 18- month visit of the placebo arm | 18 months | To evaluate the effect at 18 months of iptacopan in improving eGFR |
| Secondary | Proportion of patients achieved a composite renal endpoint | 6 and 12 months | To demonstrate the superiority of iptacopan vs. placebo in the proportion of participant who achieved a composite renal endpoint at 6 and 12 months (each study arm). |
| Secondary | Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score. | 12 months | To demonstrate the superiority of iptacopan compared to placebo in improvement of patient-reported fatigue at 12 months (each study arm). |
| Secondary | Number of participants with abnormal vital signs, ECGs and safety laboratory measurements as well as study drug discontinuation due to an AE | up to 18 months | To evaluate the safety and tolerability of iptacopan compared to placebo, number of participants with abnormal vital signs (msDBP/msSBP/heart rate), ECGs, safety laboratory measurements and study drug discontinuation due to an AE will be collected. msDBP: mean sitting diastolic blood pressure msSBP: mean sitting systolic blood pressure |
| Secondary | Number of participants with clinically significant changes in heart rate, blood pressure, echocardiography parameters in adolescent patients | up to 18 months | To evaluate the effect of iptacopan compared to placebo, number of participants with clinically significant changes in heart rate, blood pressure (msDBP/ msSBP), echocardiography parameters in adolescent patients will be collected |
| Secondary | Annualized total eGFR slope estimated over 12 months. | 12 months | To demonstrate the superiority of iptacopan vs. placebo in stabilizing eGFR |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT05755386
GET https://conductscience.org/api/trials/v1/NCT05755386/registered