Trial · NCT04287985
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Graded by Severity | Baseline to End of Study (16 months) | The number of participants who experienced adverse events, graded by maximum severity, are presented. |
| Primary | Changes From Baseline in Clinical Laboratory Tests | Baseline to End of Study (16 months) | The number of participants who experience a shift from normal at baseline to Grade 3/4 (moderate/sever) at a postbaseline time point are presented. |
| Primary | Clinically Meaningful Changes From Baseline in Vital Signs | Baseline to End of Study (16 months) | The number of participants who experienced clinically meaningful changes from baseline in vital signs (body mass index, diastolic blood pressure, height, heart rate, mean arterial pressure, respiratory rate, systolic blood pressure, temperature, and weight) are presented. |
| Primary | Clinically Significant Physical Examinations | Baseline to End of Study (16 months) | Clinically significant physical examination findings are presented. |
| Primary | Change From Baseline in uPCR: Month 12 | 12 months | Natural Log 24-Hour uPCR (Schedule A Urine Collection) Change from Baseline at Month 12: mixed model with repeated measurements |
| Secondary | Change From Baseline in uPCR: Months 9 and 16 | Baseline to 9 months and 16 months (16 months total) | Change from baseline in uPCR (Urine protein/creatinine ratio) |
| Secondary | Change in 24-hour Urine Protein Excretion: Months 12 and 16 | 16 months | Change in 24-hour urine protein excretion from baseline to Months 12 and 16 |
| Secondary | Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 | Baseline to 9,12, and 16 months (16 months total) | Number of participants in each group achieving a greater than or equal to 30% decline from baseline in urinary protein/creatinine ratio (uPCR) at Months 9, 12, and 16 |
| Secondary | Participants in Each Group Achieving Clinical Remission | Baseline to End of Study (16 months) | Number of participants in each group achieving clinical remission. Clinical remission was defined as reduction in 24-hour urine protein excretion to less than 300 mg/day for at least 3 consecutive months. |
| Secondary | Change From Baseline in eGFR at Months 9, 12, and 16 | Baseline to 12 and 16 months | Change from baseline in (eGFR) at Months 9, 12, and 16 |
| Secondary | Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16 | Baseline to 12 and 16 months | Percent change from baseline in total serum immunoglobin (Ig)A, IgG, and IgM concentrations at Months 12 and 16 in PD population |
| Secondary | Mean Serum PK Parameters at Month 0 and Month 11: Cmax | Months 0 and 11 | Serum PK parameters: maximum serum concentration (Cmax) |
| Secondary | Median Serum PK Parameters at Month 0 and Month 11: Tmax | Month 0 and Month 11 | Serum PK parameters: time of maximum serum concentration (Tmax) |
| Secondary | Mean Serum PK Parameters at Month 0: AUC0-inf and AUC0-30 | Month 0 | Serum PK parameters of area under the concentration-time curve from time 0 to infinity (AUC0-inf) and area under the concentration-time curve from time 0 to Day 30 (AUC0-30) |
| Secondary | Mean Serum PK Parameters at Month 0 and Month 11: t1/2z | Month 0 and Month 11 | Serum PK parameters: terminal elimination half-life(t1/2z) |
| Secondary | Median Serum PK Parameters at Month 0: CL | Month 0 | Serum PK parameters of clearance. 8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext \> 20% and R2 Adjusted \< 0.8. Affected parameters at participant visits meeting this criteria were excluded. |
| Secondary | Mean Serum PK Parameters at Month 0: Vz | Month 0 | Serum PK parameters of apparent volume of distribution (Vz). 8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext \> 20% and R2 Adjusted \< 0.8. Affected parameters at participant visits meeting this criteria were excluded. |
| Secondary | Mean Serum PK Parameters at Month 11: AUCτ | Month 11 | Serum PK parameters: area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) |
| Secondary | Mean Serum PK Parameters at Month 11: Vss | Month 11 | Serum PK parameters: volume of distribution at steady-state (Vss) |
| Secondary | Mean Serum PK Parameters at Month 11: CLss | Month 11 | Serum PK parameters: clearance at steady-state (CLss) |
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.
For software
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