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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 predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29
Awards & highlights
Study Summary
This trial is looking at how a single dose of olpasiran affects people with different degrees of kidney function.
Who is the study for?
This trial is for adults aged 18-75 with varying kidney function, from normal to severe impairment or on dialysis. They must have a BMI of 18-40 kg/m^2 and no active liver disease, drug allergies, or recent investigational drug use. Pregnant women and those with recent health changes are excluded.Check my eligibility
What is being tested?
The study tests how the body processes a single dose of Olpasiran in people with different levels of kidney health. It aims to understand the medication's behavior (pharmacokinetics) and effects (pharmacodynamics) across this spectrum.See study design
What are the potential side effects?
While specific side effects for Olpasiran aren't listed here, common ones may include reactions at the injection site, potential allergic responses, general discomforts like headache or nausea, and possibly altered lab results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29
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 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
Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran
+1 moreSecondary outcome measures
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])
Lipopolysaccharides
Number of Participants Who Experience an Adverse Event (AE)
+4 moreSide effects data
From 2022 Phase 2 trial • 281 Patients • NCT0427076011%
Headache
9%
Injection site pain
7%
Myalgia
7%
COVID-19
7%
Injection site erythema
7%
Non-cardiac chest pain
7%
Immunisation reaction
5%
Injection site pruritus
5%
Oedema peripheral
5%
Pain in extremity
5%
Nausea
4%
Type 2 diabetes mellitus
4%
Constipation
4%
Arthralgia
4%
Sinusitis
4%
Abdominal pain
4%
Hypertension
4%
Gastroenteritis
4%
Fatigue
2%
Atrial fibrillation
2%
Injection site reaction
2%
Diverticulitis
2%
Seizure
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
2%
Nasopharyngitis
2%
Dizziness
2%
Anaemia
2%
Upper respiratory tract infection
2%
Campylobacter infection
2%
Urticaria
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 5; Treatment Period: Placebo Q12W
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
Group 5; Extended Safety Follow-up: Placebo Q12W
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single Dose Olpasiran Renal ImpairmentExperimental Treatment1 Intervention
Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1.
Group II: Single Dose Olpasiran Normal Renal FunctionExperimental Treatment1 Intervention
Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~370
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,655 Total Patients Enrolled
1 Trials studying Kidney Failure
3,352 Patients Enrolled for Kidney Failure
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,098 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidney function is not too bad or too good, it's in the middle.Your kidney function is not too high or too low, it's in the middle range.You have a liver disease or liver function test results that are more than two times higher than the normal range.Your kidney function is normal, and you have not had any kidney problems in the past.Your kidney function, measured by eGFR, is between 15 and 29 mL/min without needing dialysis.Your kidney function is very low (eGFR < 15 mL/min) and you are on dialysis or off-dialysis.You have very low kidney function and need dialysis.Your blood potassium level is too high when checked before or at the start of the study.Your body mass index (BMI) is between 18 and 40.Participants who need kidney replacement therapy and have a certain level of kidney function will be included based on their kidney function test at the screening.
Research Study Groups:
This trial has the following groups:- Group 1: Single Dose Olpasiran Renal Impairment
- Group 2: Single Dose Olpasiran Normal Renal Function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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