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Tyrosine Kinase Inhibitor

Cohort 1 (healthy subjects) for Kidney Failure

Phase 1

Waitlist Available

Research Sponsored by Hutchison Medipharma Limited

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 day 1 to day 11

Awards & highlights

Study Summary

This trial will study how different levels of kidney function affect how the body processes Fruquintinib, a drug used to treat cancer.

Eligible Conditions

Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC 0-inf

AUC 0-t

Maximum Plasma Concentration [Cmax]

Secondary outcome measures

Incidence of AEs/SAEs

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (moderate renal impairment)Experimental Treatment1 Intervention

8 subjects with moderate renal impairment will be administered 5 mg (a x 5 mg capsule) fruquintinib

Group II: Cohort 2 (severe renal impairment)Experimental Treatment1 Intervention

8 subjects with severe renal impairment will be administered 2 mg (2 x 1 mg capsules) fruquintinib

Group III: Cohort 1 (healthy subjects)Experimental Treatment1 Intervention

8 subject with normal renal function will be administered 5mg (1 x 5 mg capsule) fruquintinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fruquintinib

Not yet FDA approved

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hutchison Medipharma LimitedLead Sponsor

100 Previous Clinical Trials

13,525 Total Patients Enrolled

HutchmedLead Sponsor

27 Previous Clinical Trials

5,322 Total Patients Enrolled

Frequently Asked Questions

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

Has Cohort 2 (severe renal impairment) achieved the necessary authorizations from the FDA?

"The safety of Cohort 2 (severe renal impairment) was appraised with a score of 1, given that the data collected in Phase 1 trials is limited when it comes to efficacy and security."

Answered by AI

Is it practicable to join the trial?

"To be eligible for this clinical trial, participants must have been diagnosed with kidney failure and meet the age parameters of 18 and 75. 24 patients will ultimately take part in this medical endeavour."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. Clinicaltrials.gov attests that this medical research is proactively looking for participants, beginning from its initial posting on March 11th 2022 and the most recent update occurring on October 5th 2022. 24 patients need to be enrolled at two distinct clinical sites."

Answered by AI

Does this research encompass geriatric patients?

"This clinical trial consists of participants aged 18 to 75. Those younger than that can check out the 6 trials designed for minors, and elderly individuals have over 150 medical studies available to them."

Answered by AI

Is recruitment still underway for this research endeavor?

"The data available on clinicaltrials.gov reveals that this research project is still recruiting participants, having been posted in March of 2022 and last updated in October of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fruquintinib Renal Impairment Study

2022. "Fruquintinib Renal Impairment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216354.