Trial · NCT06607016
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal function | day 90, day 180 | Proportion of subjects with renal function after KJ103 administration. |
| Secondary | Adverse events | day 180 | Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Secondary | Proportion and number of subjects requiring PE | day 180 | Proportion and number of subjects requiring PE after KJ103 administration. |
| Secondary | Anti-GBM antibodies | day 180 | Number of days positive for anti-GBM antibodies after KJ103 administration. |
| Secondary | Immunogenicity | day 180 | Immunogenicity of KJ103 (Anti-KJ103 antibody) in patients with anti-GBM disease. |
| Secondary | eGFR and change from baseline. | Day28, Day60, Day90, Day120, Day150, Day180 | Estimated glomerular filtration rate (eGFR). Glomerular filtration rate is an estimate of the amount of ultrafiltrate produced by each side of the kidney per unit of time and is an indicator of kidney function. |
| Secondary | Pharmacokinetics of KJ103 (Cmax) | day 7 | Maximum observed serum concentration of KJ103 following dosing (Cmax) |
| Secondary | Pharmacokinetics of KJ103 (AUC) | day 7 | Area under the serum concentration versustime curve (AUC) |
| Secondary | Pharmacokinetics of KJ103 (t1/2) | day 7 | Half-life of KJ103 |
| Secondary | Pharmacokinetics of KJ103 (CL) | day 7 | Clearance(CL) is a measure of the ability of the body to clear KJ103 |
| Secondary | Pharmacokinetics of KJ103 (Vz) | day 7 | Vz = Volume of distribution during the elimination phase |
| Secondary | Pharmacodynamic profile (Serum IgG levels) | day 180 | Serum IgG levels after KJ103 dosing |
| Secondary | Pharmacodynamics-Anti neutrophil cytoplasmic antibodies (ANCA) | day 180 | Serum Anti neutrophil cytoplasmic antibodies (ANCA) levels after KJ103 dosing |
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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GET https://conductscience.org/api/trials/v1/NCT06607016/registered