Olpasiran for Kidney Failure

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

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug Olpasiran differ from other treatments for kidney failure?

Olpasiran is unique because it is an angiotensin II type 1 receptor blocker (ARB) that not only lowers blood pressure but also has antioxidant properties, which may protect the kidneys by reducing arterial stiffness and oxidative stress. This dual action could offer additional benefits in managing kidney failure compared to standard blood pressure medications. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of once daily versus twice daily olmesartan in patients with chronic kidney disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The angiotensin II type 1 receptor blocker olmesartan preferentially improves nocturnal hypertension and proteinuria in chronic kidney disease. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Protective effect of telmisartan on rats with renal failure and its mechanism. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effects of olmesartan on arterial stiffness in rats with chronic renal failure. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

NEPHROPROTECTIVE EFFECT OF OLMESARTAN ON RENAL ISCHEMIA REPERFUSION INJURY IN MALE RATS: THE ROLE OF NRF2/HO-1 SIGNALING PATHWAY. [2023]