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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Classification at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights
Study Summary
This trial tests a drug to help people with kidney problems.
Who is the study for?
This trial is for adults with different levels of kidney function, including those on hemodialysis for at least 3 months. Participants should be in stable health and not have uncontrolled diseases or a history of significant drug allergies. Pregnant women, recent blood donors, and individuals using certain medications are excluded.Check my eligibility
What is being tested?
The study tests INCB054707's effects on people with varying kidney health. It's an open-label trial where everyone knows what treatment they're getting. The goal is to understand how the body processes the drug depending on kidney function.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to INCB054707 which could include typical drug-related issues like allergic reactions, gastrointestinal disturbances, or changes in liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is classified by eGFR and I require dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetics Parameter: AUC0-t of INCB054707
Pharmacokinetics Parameter: AUC0-∞ of INCB54707
Pharmacokinetics Parameter: Cmax of INCB054707
Secondary outcome measures
Number of Treatment Emergent Adverse Events (TEAE'S)
Pharmacokinetics Parameter: AUC3-7 of INCB054707
Pharmacokinetics Parameter: CL/F of INCB054707
+3 moreSide effects data
From 2019 Phase 2 trial • 10 Patients • NCT0356937130%
Upper respiratory tract infection
10%
Rash
10%
Night sweats
10%
Nausea
10%
Fibromyalgia
10%
Headache
10%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707
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 INCB054707 across 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB054707.
Group II: Group 4: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group III: Group 3: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group IV: Group 2: Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 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 INCB054707 75 mg on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~530
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
55,122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong medication that affects liver enzymes recently.I have used tobacco or nicotine products within the last 6 months.You have recently used alcohol or drugs, and it's not because of any allowed medications you are taking.You are allergic to INCB054707 or any of its ingredients.You cannot have blood drawn or handle having a needle inserted into your vein.Your body mass index (BMI) is between 18.0 and 40.0.I have been on hemodialysis for at least 3 months.I have a working organ transplant or will get one within 6 weeks after check-in.I haven't had cancer in the last 5 years, except for certain skin cancers or very early prostate cancer.I haven't had serious heart, lung, liver, stomach, hormone, blood, mental health, or nerve issues in the last 6 months.I have not had a blood transfusion in the last 4 weeks.I am currently on treatment for a long-term or active infection.I have tested positive and show symptoms for HBV, HCV, or HIV.I haven't had a serious infection or been on antibiotics in the last 30 days.I am not pregnant or breastfeeding.You have had a bad reaction to any important medication in the past, as determined by the doctor.I am eligible for Group 1 and have had kidney problems as shown by tests.I have no significant GI issues or surgeries affecting medication absorption, except for gallbladder or appendix removal.I do not have any serious heart conditions that would make it unsafe for me to join the study.I have not had major surgery in the last 4 weeks.I haven't taken any experimental drugs recently or am not currently in another drug study.I haven't taken prescription drugs in the last 14 days or nonprescription in the last 7 days.I haven't received any live vaccines in the last 3 months and don't plan to during the study.I have taken prescription drugs recently, except for stable renal disease treatment.My kidney function is classified by eGFR and I require dialysis.I am in good health with no significant medical issues found in recent exams.Your heart takes too long to recharge between beats.You have had a problem with alcohol in the last 3 months.You are in Group 1 and have abnormal liver function test results during screening.My liver function tests are outside the normal range.I smoke more than 10 cigarettes a day or use equivalent tobacco products and won't stop on dosing days.You are in Groups 2 through 5 and your medical history shows a significant change in your disease in the last 30 days.I am in Group 5 and not expected to need HD treatment during the study.You have eaten certain types of citrus fruits or juices within 3 days before starting the study drug.My kidney function matches my level of kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4: Severe Renal Impairment
- Group 2: Group 1: Normal Renal Function
- Group 3: Group 3: Moderate Renal Impairment
- Group 4: Group 5: Kidney Failure
- Group 5: Group 2: Mild Renal Impairment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the principal aims of this trial?
"This clinical trial will take place over a four day period and its primary aim is to evaluate the Cmax of INCB054707. Secondary objectives include measuring tmax, t½ and Vz/F for the same medication during Group 5 Period 1 dialysis."
Answered by AI
Are there still vacancies for participants in this clinical experiment?
"Unfortunately, the record on clinicaltrials.gov divulges that this trial is not presently recruiting patients. Although first posted in November 2022 and last updated on the 15th of said month, participants should know there are 607 other studies actively enrolling at this time."
Answered by AI
Who is eligible to take part in this clinical experiment?
"If a patient is aged between 18 and 82, has kidney disease, and desires to participate in this trial, they may be eligible. This medical study will accept up to 48 enrollees."
Answered by AI
Has the FDA authorized Group 3: Moderate Renal Impairment?
"Group 3: Moderate Renal Impairment has limited safety and efficacy data, so it's assigned a 1 on the scale."
Answered by AI
Does this research program enlist participants who are greater than eighty-five years old?
"This medical trial is open to people aged between 18 and 82 years old. For those below the age of consent, 46 different studies are available; conversely, there are 565 trials for seniors over 65."
Answered by AI
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