← Back to Search

RNAi

Olpasiran for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Amgen
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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29 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 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 more
Secondary 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 more

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04270760
11%
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 4; Treatment Period: Olpasiran 225 mg Q24W
Group 5; Treatment Period: Placebo Q12W
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
1,382 Previous Clinical Trials
1,379,650 Total Patients Enrolled
1 Trials studying Kidney Failure
3,352 Patients Enrolled for Kidney Failure
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,697 Total Patients Enrolled

Media Library

Olpasiran (RNAi) Clinical Trial Eligibility Overview. Trial Name: NCT05489614 — Phase 1
Kidney Failure Research Study Groups: Single Dose Olpasiran Renal Impairment, Single Dose Olpasiran Normal Renal Function
Kidney Failure Clinical Trial 2023: Olpasiran Highlights & Side Effects. Trial Name: NCT05489614 — Phase 1
Olpasiran (RNAi) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489614 — Phase 1
~12 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top