Trial · NCT04620239
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter | 28 +/- 3 days post last treatment | Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection |
| Secondary | Duration of response at the entire ipsilateral kidney | 12 months post PRE | The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 12 months maintenance treatment visit post PRE |
| Secondary | Duration of response at the entire ipsilateral kidney | 3, 6, 9 months post PRE | The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 3, 6, 9 months maintenance treatment visits post PRE |
| Secondary | Duration of response at the Treatment Area of the ipsilateral kidney | 3, 6, 9, and 12 months post PRE | Duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 3, 6, 9, and 12 months maintenance treatment visits post PRE |
| Secondary | Overall renal function | 6 and 12 months post PRE | Overall renal functional outcome will be measured at the 6 and 12 months maintenance treatment visits post PRE, and will be evaluated by comparing pre-treatment and 12-month estimated glomerular filtration rate (eGFR), calculated from serum creatinine levels, using the CKD-Epi method including: * Absolute change in eGFR as well as categories of CKD will be utilized based on KDIGO 2012 criteria * Description will include change in eGFR, change in CKD stage/risk category |
| Secondary | Kidney organ loss or preservation | 3, 6, 9, and 12 months post PRE | Kidney organ loss or preservation will be recorded at each maintenance treatment visit post PRE at 3, 6, 9, and 12 months Maintenance Treatment visits, and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss. |
| Secondary | Pathological evaluation of response | After at least one VTP treatment | PathologicalPathological evaluation of response will be performed in kidney tissue of patients that will undergo kidney surgical removal (kidney sparing, or radical nephroureterectomy) following at least one padeliporfin VTP treatment |
| Secondary | Patients with ureteral obstruction and/or ureteral stent | Baseline 12 months | Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted with radiographic evidence of pre-existing obstruction documented, to demonstrate the site and degree of obstruction with retrograde pyelography at baseline (prior to treatment) and will be repeated and recorded at 12 months maintenance treatment visit (post treatment) which will further be supported with CT Urogram results at 12 months to demonstrate the site and degree of obstruction using standard nomenclature. |
| Secondary | Long Term follow-up Duration of the response | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | The duration of response in the ipsilateral kidney and treatment area will be defined as absence of disease, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if present and performed) |
| Secondary | Long Term follow-up Kidney organ loss or preservation | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | Kidney organ loss or preservation will be recorded and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss and a pathology report of the removed tissue will be recorded (if available or feasible) |
| Secondary | Long Term follow-up Overall renal functional | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | Overall renal functional outcome will be evaluated by estimated glomerular filtration rate(eGFR) using CKD-Epimethod |
| Secondary | Long Term follow-up Safety Follow up | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | Safety follow up based and recording of adverse events |
| Secondary | Exploratory Endpoint | Baseline | Blood,tumor and cytology samples will be collected, centrally stored and later submitted for tumor genomic sequencing studies to explore the tumor genomic alterations, and mutation status as biomarkers with association to treatment response and progression events such as recurrence, grade transformation, increased stage and metastases. |
| Secondary | Pharmacokinetic Endpoint Cmax | 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection | Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Cmax |
| Secondary | Pharmacokinetic Endpoint Tmax | 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection | Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Tmax |
| Secondary | Pharmacokinetic Endpoint T1/2 | 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection | Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate T1/2 |
| Secondary | Pharmacokinetic Endpoint AUC | 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection | Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate AUC |
| Secondary | Pharmacokinetic Endpoint CL | 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection | Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate CL |
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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