What side effects are associated with this type of intervention?

Common treatments for kidney failure, particularly those involving pharmacokinetics and renal impairment, can have several side effects. Immunosuppressive therapies, such as cyclophosphamide and prednisone, can cause side effects like increased infection risk, gastrointestinal distress, and hypertension. Nephrotoxic agents, including certain chemotherapy drugs like carfilzomib, can lead to acute kidney injury, electrolyte imbalances, and fatigue. Additionally, medications like PCSK9 inhibitors, used to manage cardiovascular risk in patients with renal impairment, may cause injection site reactions, flu-like symptoms, and elevated liver enzymes. Monitoring and dose adjustments are often necessary to mitigate these side effects.

What prior FDA approvals exist?

FDA-approved treatments for kidney failure often include medications that manage symptoms and complications, such as antihypertensives, diuretics, and phosphate binders. Immunosuppressive drugs like tacrolimus and mycophenolate mofetil are used in kidney transplant patients to prevent rejection. Ezetimibe has been shown to be safe and effective in hypercholesterolemic kidney transplant patients, reducing the decline of renal function. While specific treatments like PF-07923568 for RSV in the context of kidney function are not detailed, the focus remains on managing underlying conditions and preventing further renal damage.

What other types of research exist?

Promising alternatives to PF-07923568 for kidney failure patients include TRF-budesonide, which has shown efficacy in stabilizing eGFR and reducing proteinuria in patients with IgA nephropathy. Additionally, calcineurin inhibitors (CNIs) like cyclosporine and tacrolimus have demonstrated higher rates of complete remission of proteinuria in small studies. These treatments are noteworthy for their potential benefits in managing kidney function and related complications.

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PF-07923568 for Kidney Failure

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb.)

Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening

Must not have

Renal allograft recipients

History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how a new medicine for lung infections works in people with reduced kidney function. Participants will take the medicine once and stay in the clinic for a short period for monitoring. The goal is to see if kidney issues change how the body handles the medicine.

Who is the study for?

This trial is for adults with varying levels of kidney function loss, who haven't had a kidney transplant or don't need hemodialysis. They should have stable kidney function as shown by tests and meet specific body weight criteria. People with recent drug abuse history, certain infections like HIV or hepatitis, or those on other clinical trials can't participate.

What is being tested?

The study is testing PF-07923568, a potential treatment for RSV infection in people with reduced kidney function. Participants will take the medication orally once and stay at the clinic for about 5 days while their blood is tested to see how their kidneys process the drug.

What are the potential side effects?

Potential side effects are not detailed here but monitoring during the clinic stay suggests they're looking out for any adverse reactions to PF-07923568 related to its processing by impaired kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 16 and 32, and I weigh more than 99 lbs.

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My kidney function has been stable recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received a kidney transplant.

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I have a history of HIV, hepatitis B, or hepatitis C.

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I have a sudden kidney condition.

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I have severe kidney damage.

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I require hemodialysis.

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I have had a kidney, liver, or heart transplant.

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

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (Optional): Moderate Renal ImpairmentExperimental Treatment1 Intervention

Participants with moderate renal impairment will receive a single oral dose of PF-07923568

Group II: Cohort 2: Normal Renal FunctionExperimental Treatment1 Intervention

Participants with normal renal function will receive a single oral dose of PF-07923568

Group III: Cohort 1: Severe Renal ImpairmentExperimental Treatment1 Intervention

Participants with severe renal impairment will receive a single oral dose of PF-07923568

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drug: PF-07923568

2023

Completed Phase 1

~20

0 / 8Eligibility criteria met

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

The most common treatments for kidney failure include dialysis, kidney transplantation, and medications to manage symptoms and complications. Dialysis mechanically filters waste products and excess fluids from the blood, mimicking the natural function of healthy kidneys. Kidney transplantation involves replacing the failed kidney with a healthy donor kidney, restoring normal kidney function. Medications such as ACE inhibitors, ARBs, and diuretics help control blood pressure, reduce proteinuria, and manage fluid balance. Understanding the pharmacokinetics of drugs like PF-07923568 in patients with kidney failure is crucial because impaired kidney function can alter drug metabolism and excretion, necessitating dosage adjustments to avoid toxicity and ensure therapeutic efficacy.