What side effects are associated with this type of intervention?

Common treatments for kidney failure, such as ACE inhibitors, NSAIDs, and certain chemotherapeutic agents, can have significant side effects. ACE inhibitors may cause hyperkalemia, hypotension, and renal dysfunction. NSAIDs are known for their potential to induce acute kidney injury, especially in patients with pre-existing renal impairment. Chemotherapeutic agents like carfilzomib can lead to acute kidney injury, thrombotic microangiopathy, and electrolyte imbalances. It is crucial to monitor renal function and adjust dosages accordingly to mitigate these risks.

What prior FDA approvals exist?

FDA-approved treatments for kidney failure often include immunosuppressive therapies such as calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mammalian target of rapamycin (mTOR) inhibitors (e.g., sirolimus, everolimus), and antimetabolites (e.g., mycophenolate mofetil, azathioprine). These drugs are used to prevent rejection in kidney transplant patients and manage chronic kidney disease. Additionally, treatments like erythropoiesis-stimulating agents (e.g., epoetin alfa) are approved to manage anemia associated with kidney failure. While Olpasiran is still under investigation, its study in patients with renal impairment aligns with the ongoing need to understand the pharmacokinetics and safety of new treatments in this population.

What other types of research exist?

Promising alternatives to Olpasiran for kidney failure patients include Sacubitril/Valsartan, which has shown favorable renal outcomes in heart failure patients, including those undergoing peritoneal dialysis and hemodialysis. Additionally, treatments like Afatinib and Erdafitinib have been studied for their pharmacokinetics in patients with renal impairment and may offer potential benefits.

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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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called olpasiran to see how it behaves in the body. It includes people with healthy kidneys and those with kidney problems. The goal is to understand how the drug is absorbed, used, and removed from the body in these different groups.

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04270760

19%

COVID-19

Urinary tract infection

Upper respiratory tract infection

Anaemia

Contusion

Cellulitis

Fatigue

Arthralgia

Pain in extremity

Cough

Oedema peripheral

Nasopharyngitis

Fall

Hypertension

Abdominal pain

Headache

Femur fracture

Sinusitis

Type 2 diabetes mellitus

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W

Group 5; Treatment Period: Placebo Q12W

Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W

Group 4; Treatment Period: Olpasiran 225 mg Q24W

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure include plasmapheresis, immunosuppressive therapy, and angiotensin inhibitors. Plasmapheresis works by removing circulating antibodies and inflammatory mediators, which is crucial for conditions like anti-GBM disease. Immunosuppressive agents, such as cyclophosphamide and prednisone, minimize new antibody formation and reduce inflammation, helping to preserve kidney function. Angiotensin inhibitors, like enalapril, lower blood pressure and reduce proteinuria, which can slow the progression of kidney damage. Understanding these mechanisms is vital for kidney failure patients as they directly impact the effectiveness of treatment and the potential for recovery or stabilization of kidney function.

Pharmacological management of acute kidney injury and chronic kidney disease in neonates.