Cohort 2 (severe renal impairment) for Kidney Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kidney Failure+1 More
Fruquintinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • deteriorating renal function

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Day 1 to Day 11

Day 11
AUC 0-inf
AUC 0-t
Incidence of AEs/SAEs
Maximum Plasma Concentration [Cmax]

Trial Safety

Trial Design

3 Treatment Groups

Cohort 2 (severe renal impairment)
1 of 3
Cohort 1 (healthy subjects)
1 of 3
Cohort 3 (moderate renal impairment)
1 of 3
Experimental Treatment

24 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 2 (severe renal impairment) · No Placebo Group · Phase 1

Cohort 2 (severe renal impairment)
Drug
Experimental Group · 1 Intervention: Fruquintinib · Intervention Types: Drug
Cohort 1 (healthy subjects)
Drug
Experimental Group · 1 Intervention: Fruquintinib · Intervention Types: Drug
Cohort 3 (moderate renal impairment)
Drug
Experimental Group · 1 Intervention: Fruquintinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruquintinib
2022
Completed Phase 3
~790

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 11

Who is running the clinical trial?

HutchmedLead Sponsor
13 Previous Clinical Trials
1,153 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
99 Previous Clinical Trials
13,754 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female between the ages of 18 and 82 years old (inclusive).
You are female and not of childbearing potential or surgically sterile.
You have no clinically significant change in clinical condition within the last 30 days before screening.
You have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.