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Antiparasitic Agent

Healthy Control Match (RF ≥ 90 mL/min) for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Genfit
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 d1:predose;1;2;3;4;5;6;7;8;10;12h post dose; d2-6:predose; d7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(d8);48(d9);72(d10) and 96(11)h post-dose.urine:d1 predose; 0-4; 4-8; 8-12 h post morning dose; d7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Awards & highlights

Study Summary

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.

Eligible Conditions
  • Kidney Failure
  • Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day (d) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; d7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day (d) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; d7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose 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 from time zero to 12h (AUC0-12)
Area under the plasma concentration time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
AUC0-12 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
AUC0-12 for the NTZ major active metabolite
AUC0-t after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
+22 more

Side effects data

From 2019 Phase 3 trial • 1030 Patients • NCT03336619
15%
Chromaturia
7%
Diarrhoea
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nitazoxanide

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe Renal Impairment (RF < 30 mL/min and not on dialysis)Experimental Treatment1 Intervention
500 mg Twice Daily for 7 days
Group II: Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)Experimental Treatment1 Intervention
500 mg Twice Daily for 7 days
Group III: Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)Experimental Treatment1 Intervention
500 mg Twice Daily for 7 days
Group IV: Healthy Control Match (RF ≥ 90 mL/min)Experimental Treatment1 Intervention
500 mg Twice Daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitazoxanide
2013
Completed Phase 4
~8390

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GenfitLead Sponsor
19 Previous Clinical Trials
3,428 Total Patients Enrolled
Carol Addy, MDStudy DirectorGenfit
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
2022. "Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368935.
~26 spots leftby May 2025
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