Single Dose Olpasiran Renal Impairment for Kidney Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nucleus Network, Saint Paul, MNKidney FailureOlpasiran - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is looking at how a single dose of olpasiran affects people with different degrees of kidney function.

Eligible Conditions
  • Kidney Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

Day 4
Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran
Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran
Maximum Observed Serum Concentration (Cmax) of Olpasiran
Day 85
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])
Lipopolysaccharides
Time to Reach Imax of Lp(a)
Up to Day 85
Number of Participants Who Experience an Adverse Event (AE)
Electrocardiogram
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations
Number of Participants with Clinically Significant Changes in Vital Signs

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

Single Dose Olpasiran Renal Impairment
1 of 2
Single Dose Olpasiran Normal Renal Function
1 of 2

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Single Dose Olpasiran Renal Impairment · No Placebo Group · Phase 1

Single Dose Olpasiran Renal Impairment
Drug
Experimental Group · 1 Intervention: Olpasiran · Intervention Types: Drug
Single Dose Olpasiran Normal Renal Function
Drug
Experimental Group · 1 Intervention: Olpasiran · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~320

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29

Who is running the clinical trial?

AmgenLead Sponsor
1,301 Previous Clinical Trials
1,330,145 Total Patients Enrolled
1 Trials studying Kidney Failure
3,352 Patients Enrolled for Kidney Failure
MDStudy DirectorAmgen
843 Previous Clinical Trials
899,438 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) falls within the range of 18 to 40 kg/m^2 during the screening process.
References

Frequently Asked Questions

Is there still capacity for participants in the clinical trial?

"Indeed, the information on clinicaltrials.gov confirms that this trial is presently recruiting participants. This experiment was initially posted on September 13th 2022 and has been modified as recently as November 16th 2022. 32 patients need to be enrolled from 5 different medical centres." - Anonymous Online Contributor

Unverified Answer

Is the age cutoff for this experiment set at 40 years or higher?

"This medical study is open to individuals aged 18 or more and 75 years old or less." - Anonymous Online Contributor

Unverified Answer

Are there numerous facilities carrying out this clinical trial in the US?

"Numerous medical centres are actively seeking participants for this trial, such as Nucleus Network - Minneapolis in Orlando, Orlando Clinical Research Center in Rialto, and Inland Empire Clinical Trials LLC in Miami." - Anonymous Online Contributor

Unverified Answer

How much risk does a one-time dose of Olpasiran Renal Impairment pose to individuals?

"As this is only a Phase 1 trial, with limited data supporting efficacy and safety, Single Dose Olpasiran Renal Impairment received an approximate score of 1." - Anonymous Online Contributor

Unverified Answer

How many participants have signed up for this investigation?

"This trial requires 32 participants who meet its specific criteria. These enrollees may come from Nucleus Network in Minneapolis, Minnesota and Orlando Clinical Research Center located in Rialto, California." - Anonymous Online Contributor

Unverified Answer

What criteria must be met to qualify for this research project?

"This clinical trial is in search of 32 participants with declining renal health who are aged between 18 and 75." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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