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Study Summary
This trial will test the effects of a new drug on people with different levels of kidney function.
- Kidney Failure
- Hemodialysis
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
How many participants have been accepted for participation in this clinical study?
"Affirmative. The details on clinicaltrials.gov attests that this research is currently accepting participants, having been posted on December 14th 2021 and last updated July 20th 2022. A total of 48 patients are needed to be enrolled from 5 distinct medical facilities."
Are there numerous medical facilities in Canada currently running this trial?
"Currently, this clinical trial is recruiting participants from 5 different medical centres. These locations include Miami, Hialeah and Saint Paul among other cities. To reduce travelling commitments that may come with participating in the study, it is advised to select a clinic closest to your residence."
Does my profile meet the qualifications for this clinical investigation?
"This clinical trial is seeking 48 people, aged 18 to 82 years old, who are suffering from deteriorating renal function. The following criteria must be met in order to qualify: Willingness to comply with contraception measures outlined in the protocol; Body mass index between 18 and 40 kg/m2; Ability to swallow and absorb oral medication; No clinically significant deviations from normal based on medical history, physical examination, vital signs and ECG results (for Groups 1-4); Must have received haemodialysis for at least 3 months prior if applicable (Group 5)."
Is the cutoff age for this clinical testing below 20 years old?
"Only those aged 18 to 82 can be included in this trial. There are 6 studies dedicated exclusively to minors and 186 specifically targeting senior citizens."
Has the Food and Drug Administration authorized INCB000928?
"The clinical data available on INCB000928 suggests that its safety ranking is a 1, as this medication has only been tested in Phase 1 trials and thus the evidence of both efficacy and safety are limited."
Is admission to this experiment open for individuals at the present time?
"Yes, the information hosted on clinicaltrials.gov indicates that enrolment for this trial is currently underway. The posting was initially made in December 2021 and underwent its most recent update June 2022; participants from 5 different sites are being sought out to bring the total number of enrolled individuals up to 48."
What ultimate outcome is hoped for from this research?
"The sponsor of this trial, Incyte Corporation, has reported that the primary endpoint will be plasma PK for INCB000928: Cmax over a 4 day period. Additionally, secondary endpoints related to Vz/F (apparent oral dose volume of distribution), tmax (time to maximum concentration) and CL/F (apparent oral dose clearance) are also being assessed."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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