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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 weeks
Treatment ~ Varies
Follow Up ~day 1 to 29 (total duration: 29 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 29 (total duration: 29 days) for reporting.

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

Find a Location

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
61,089 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment admit participants above the age of 25?

"This medical research is open to participants aged 18-80; however, there are additional studies available for those under the age of 18 and above 65. Specifically, 6 trials exist for minors whereas 143 cater to seniors."

Answered by AI

Does Severe renal impairment pose any risks to individuals?

"Given the limited clinical data available, Severe renal impairment was given a rating of 1 on our scale. This phase one trial has yet to provide significant evidence regarding efficacy and safety."

Answered by AI

Is enrollment for this research program currently available to participants?

"Indeed, the details available from clinicaltrials.gov state that this trial is actively enrolling patients and has been since December 2nd 2022. As of January 25th 2023, 32 participants are required for 4 different locations."

Answered by AI

What is the prevalence of medical research centers conducting this trial in Canada?

"Patients for this medical trial are being recruited from 4 distinct sites, such as Panax Clinical Research in Miami Lakes and Clinical Pharmacology of Miami. Additionally, AMR Knoxville is participating in the study along with other venues across the US."

Answered by AI

What is the scale of recruitment for this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was first announced on December 2nd 2022, is currently recruiting participants. 32 patients are needed for the trial and it will be conducted at 4 distinct medical centres."

Answered by AI

Based on the criteria, could I be accepted into this medical research project?

"This medical study is enrolling 32 people who have been diagnosed with renal insufficiency, and must be between 18-80 years old. Notably, applicants should fit the following criteria: Have a calculated glomerular filtration rate (GFR) <30ml/min/1.73m2 but not necessitate dialysis; GFR of 30ml/min/1.73m2 to 60 ml/min/1.73m2 for moderate impairment; Normal kidney functionality at ≥90mls//min7173msquared, willingness to participate in this study after signing an approved informed consent form by the"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function
2022. "Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05711381.
~7 spots leftby Apr 2025
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