Trial · NCT04154787
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | Baseline, Day 113, Day 169 | The primary endpoint of this study is the ratio between UPCR at 24 weeks of treatment measured in 24h urine and baseline UPCR . To assess the primary objective, the log-transformed ratio to baseline in UPCR was analyzed using a mixed model for repeated measures (MMRM). The results were back transformed and presented on the original scale. |
| Secondary | Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | Baseline, Day 15, Day 29, Day 57, Day 113 and Day 169 | The drug (LNP023) is expected to block the complement alternative pathway dysregulation and thereby should normalize complement biomarker levels in serum. Bb is a biomarker that accurately reflects the level of complement Alternative Pathway activation. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. |
| Secondary | Change From Baseline in Plasma Levels of sC5b-9 | Baseline, Day 15, Day 29, Day 57, Day 113, Day 169 | Soluble C5b-9 (sC5b-9) is a biomarker of the complement pathway activity that correlate with disease progression. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. |
| Secondary | Ratio to Baseline of Urine Protein Creatinine Ratio (UPCR) Measured in First Morning Void | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266 and Day 378 | Adjusted geometric mean ratio to baseline of Urine Protein Creatinine Ratio (UPCR) measured in first morning void. First morning void urine sample was collected in the morning of the day before the visit and kept in the fridge. |
| Secondary | Number of Participants by Treatment Response at 24 Weeks of Treatment | Baseline, Day 169 | Participants were considered complete responders if at 24 weeks of treatment, they showed complete remission of proteinuria (i.e., Urine Protein (UP) ≤ 0.3 g/24h), partial responders if they showed partial remission (i.e., UP \> 0.3g/24h and ≤ 3.5 g/24h and a reduction of UP by \>50% from baseline), and non-responders if UP \>3.5g/24h and/or reduction of UP from baseline \<50%. |
| Secondary | Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | Changes in renal function were assessed via estimated glomerular filtration rate (eGFR). Change in eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. |
| Secondary | Pharmacokinetic Parameter Tmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023 : Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time). Actual sampling time points were considered for the calculation of PK parameters. |
| Secondary | Pharmacokinetic Parameter Cmax in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023: Cmax is the maximum (peak) observed plasma drug concentration after dose administration (mass x volume-1) |
| Secondary | Pharmacokinetic Parameter AUClast in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023: AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) |
| Secondary | Pharmacokinetic Parameter AUCtau in Plasma | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) | Pharmacokinetics of LNP023 : AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1) |
| Secondary | Pharmacokinetics in Urine: Renal Plasma Clearance Derived From 24 Hour Urine Sample | Day 113 | Pharmacokinetics of LNP023 in urine: Renal plasma clearance derived from 24 hour urine sample |
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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