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Severe renal impairment for Kidney Failure
Phase 1
Waitlist Available
Research Sponsored by Hanmi Pharmaceutical Company 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 29 (total duration: 29 days)
Awards & highlights
Study Summary
This trial tests a new drug in people with and without kidney problems to see if it is safe and how it is processed by the body.
Eligible Conditions
- Kidney Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to 29 (total duration: 29 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 29 (total duration: 29 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the concentration-time curve from extrapolated to infinity (AUC 0-infinity)
Maximum serum concentration (Cmax)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Severe renal impairmentExperimental Treatment1 Intervention
Group II: Normal renal impairmentExperimental Treatment1 Intervention
Group III: Moderate renal impairmentExperimental Treatment1 Intervention
Group IV: Mild renal impairmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HM15912
2022
Completed Phase 1
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
190 Previous Clinical Trials
61,090 Total Patients Enrolled
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