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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 8 for reporting.

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 more

Trial 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

~8 spots leftby Mar 2025