Olpasiran for Kidney Failure

No longer recruiting at 6 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Active liver disease, Hyperkalemia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body processes a new drug called olpasiran in people with varying levels of kidney function. The study includes patients with normal kidney function and those at different stages of kidney impairment, including kidney failure. Participants will receive a single dose of olpasiran to help researchers understand its behavior in the body. This trial may suit individuals with kidney issues, whether or not they require dialysis, and those who have not experienced significant recent changes in their kidney condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that olpasiran is likely to be safe for humans?

Research has shown that olpasiran is generally safe and well-tolerated. In previous studies, participants taking olpasiran did not report any serious side effects. Ongoing research supports these findings, indicating that olpasiran does not cause major issues for users. However, more studies are needed to fully confirm its safety. This trial aims to provide more insight into how the body processes olpasiran, particularly in individuals with varying kidney function levels. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney failure?

Olpasiran is unique because it offers a new approach to addressing kidney failure. While most treatments focus on managing symptoms or slowing disease progression, Olpasiran targets a specific molecular pathway that could potentially alter the course of the disease itself. Researchers are excited about Olpasiran because it uses an innovative mechanism of action, potentially leading to more effective interventions with fewer side effects. This treatment could bring hope to patients by offering a more direct and potentially faster-acting solution compared to current options.

What evidence suggests that olpasiran might be an effective treatment for kidney failure?

Research has shown that olpasiran can greatly reduce lipoprotein(a) levels. In studies, patients who took olpasiran experienced a 40% to 50% drop in these levels, even up to a year after their last dose. This reduction is significant because high levels of lipoprotein(a) are linked to heart disease. Olpasiran works by using a special molecule that stops certain genes from making harmful proteins. In this trial, participants with varying levels of renal function, including those with kidney failure, will receive a single dose of olpasiran. Although there is limited information on its effects on kidney failure, its ability to lower harmful proteins is promising. ^{1 2 3 4 5}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Your kidney function is normal, and you have not had any kidney problems in the past.

Exclusion Criteria

History of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor

Female participants with a positive pregnancy test at Screening or Check-in

Participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to Check-in

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of olpasiran on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olpasiran

Trial Overview 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.

How Is the Trial Designed?

Group I: Single Dose Olpasiran Renal Impairment Experimental Treatment 1 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 Function Experimental Treatment 1 Intervention

Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05489614?term=Olpasiran&rank=3

NCT05489614 | A Study to Evaluate the Pharmacokinetics, ... The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2024.05.058

The Off-Treatment Effects of Olpasiran on Lipoprotein(a) ... Olpasiran is a potent siRNA with prolonged effects on Lp(a) lowering. Participants receiving doses ≥75 mg Q12W sustained a ∼40% to 50% reduction in Lp(a) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S073510972407671X

The Off-Treatment Effects of Olpasiran on Lipoprotein(a) ... Participants receiving higher doses of olpasiran sustained a ∼40% to 50% placebo-adjusted mean reduction in Lp(a) levels close to 1 year after the last dose ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2211023

Small Interfering RNA to Reduce Lipoprotein(a) in ... Olpasiran therapy significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease.

5. amgentrials.com amgentrials.com/study/?id=20220010

AMGEN - A Study to Evaluate the Pharmacokinetics, Safety ... The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and ...