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INCB000928 for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-4 and follow up; up to 14 days
Awards & highlights

Study Summary

This trial will test the effects of a new drug on people with different levels of kidney function.

Eligible Conditions
  • Kidney Failure
  • Hemodialysis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-4 and follow up; up to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-4 and follow up; up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK for plasma of INCB000928: AUC0-t
PK for plasma of INCB000928: AUC0-∞
PK for plasma of INCB000928: Cmax
Secondary outcome measures
Number of treatment-related adverse events
PK for plasma of INCB000928: AUC3-7
PK for plasma of INCB000928: CL/F
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Group 5: Kidney FailureExperimental Treatment1 Intervention
Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928.
Group II: Group 4: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group III: Group 3: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group IV: Group 2: Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group V: Group 1: Normal Renal FunctionExperimental Treatment1 Intervention
Participants with normal levels of renal function will receive a single oral dose of INCB000928 200 mg on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB000928
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Advanced Pharma
What portion of applicants met pre-screening criteria?
Did not meet criteria
~14 spots leftby Apr 2025