Trial · NCT03955445
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | CLNP023X2202: Status of C3G disease progression | 6 to 9 month visit | Describe the status of C3G disease progression based on glomerular histopathology in a renal biopsy at 6 to 9 months from entry to the study compared to those obtained prior to treatment in the CLNP023X2202 study |
| Secondary | CLNP023X2202: Log-transformed ratio to baseline in serum C3 | 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 C3 by evaluating the Log-transformed ratio to baseline in serum C3 |
| Secondary | CLNP023X2202: Number of participants who achieve the composite renal endpoint | Up to 66 months | A participant is defined as achieving the composite renal endpoint if they meet the following criteria at times \>9 months 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., LLN). 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: Plasma LNP023 concentration up to 12 months at trough | 3-months, 6-months, 9-months and 12-months visits | Measurement of LNP023 plasma concentration to evaluate the pharmacokinetics of iptacopan in participants with prolonged treatment |
| Secondary | CLNP023B12301 and CLNP023B12302: Change from initiation of iptacopan treatment in the core study in log-transformed UPCR over time. | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Change from initiation of iptacopan treatment in the core study in log-transformed UPCR will be assessed to evaluate the long-term effect of iptacopan on proteinuria |
| Secondary | CLNP023B12301 and CLNP023B12302: Change from initiation of iptacopan treatment in the core study in eGFR over time. | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | Change from initiation of iptacopan treatment in the core study in eGFR over time will be assessed to evaluate the long-term effect of iptacopan on eGFR |
| Secondary | CLNP023B12301 and CLNP023B12302: Number of participants who achieve a 2-component composite renal endpoint | Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months | A participant is defined as meeting the requirements of the composite renal endpoint if they satisfy the eGFR (a stable or improved eGFR, i.e., ≤15% reduction in eGFR compared to the initiation of iptacopan treatment in the core study) and UPCR (≥50% reduction in UPCR compared to the initiation of iptacopan treatment in the core study) criteria assessed at a visit. Initiation of any complement pathway modifying agent or initiation/intensification of corticosteroid or immunosuppressant therapy, or renal replacement therapy automatically designates the participant as not having met the endpoint. The rate will be evaluated over time. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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