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Bruton's Tyrosine Kinase (BTK) Inhibitor
tolebrutinib for Kidney Failure
Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant with platelet count ≥150 000/μL at the screening visit and at Day -1
Body weight between 50.0- and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) between 18 to 40 kg/m2 inclusive, at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 8
Awards & highlights
Study Summary
This trial is testing whether a drug is safe and works well in people with different levels of kidney function.
Eligible Conditions
- Kidney Failure
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of PK parameters M2: AUC
Assessment of PK parameters Tolebrutinib: AUC
Secondary outcome measures
Assessment of PK parameters M2: AUClast
Assessment of PK parameters M2: Cmax
Assessment of PK parameters Tolebrutinib: AUClast
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Severe Renal Impairment (RI) group (Part A only)Experimental Treatment1 Intervention
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
Group II: Normal Renal Function group (Part A and B)Experimental Treatment1 Intervention
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
Group III: Moderate RI group (Part B only conditional)Experimental Treatment1 Intervention
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tolebrutinib
2022
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,324 Total Patients Enrolled
3 Trials studying Kidney Failure
173 Patients Enrolled for Kidney Failure
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,931 Total Patients Enrolled
1 Trials studying Kidney Failure
12 Patients Enrolled for Kidney Failure
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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