PF-07817883 for Kidney Failure

No longer recruiting at 2 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Compensation: Varies

Number of Visits: 5

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PF-07817883 (also known as Ibuzatrelvir) to understand its processing in the body and assess its safety. It targets individuals with varying kidney function levels: moderate, severe, or healthy. Participants will spend a few days in a clinic to receive the treatment and undergo blood tests. Those with stable kidney health, willing to stay at the clinic for a few days, might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. Please consult with the study coordinators for more details.

Is there any evidence suggesting that PF-07817883 is likely to be safe for humans?

Research shows that PF-07817883 is a new oral medication developed to treat COVID-19. It has undergone studies for safety and effectiveness in people. While specific safety information for patients with kidney failure is not available, PF-07817883 has been tested in other studies and is generally well-tolerated. This study is in its early stages, focusing on understanding the drug's mechanism in the body and its safety. Early trials typically involve a small number of participants to closely monitor any side effects. The goal is to ensure the treatment is safe enough for testing in larger groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney failure, which often involve dialysis or transplant, PF-07817883 represents a new approach by potentially targeting the underlying causes of renal impairment. Researchers are excited about this treatment because it offers a novel mechanism of action that could improve kidney function directly, rather than just managing symptoms. Additionally, PF-07817883 could lead to more personalized treatment options, as it is being studied across different levels of renal impairment, allowing for tailored therapies that match the severity of the condition. This innovative approach holds promise for enhancing patient outcomes and quality of life.

What evidence suggests that PF-07817883 might be an effective treatment for kidney failure?

Research on PF-07817883, also known as Ibuzatrelvir, remains in the early stages, so limited information exists about its effectiveness in treating kidney failure. This trial explores its potential benefits for individuals with varying levels of kidney problems. Participants will be divided into cohorts based on kidney function: no renal impairment, moderate renal impairment, and severe renal impairment. The drug is designed to be processed in a way that might be safe for those with kidney issues. Early studies examine how the drug is absorbed and tolerated by individuals with different kidney functions. The goal is to ensure its safe use in people with moderate to severe kidney damage. Further research is needed to confirm its effectiveness in treating kidney conditions. ^{3 5 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 90 with varying levels of kidney function, including moderate and severe impairment or no damage at all. Participants must have a stable renal function as indicated by eGFR values and meet body weight requirements. They should be willing to stay in the clinic for an extended period.

Inclusion Criteria

My BMI is at least 16 and I weigh more than 99 lbs.

My kidney function is stable, with eGFR values not varying more than 25%.

Exclusion Criteria

I have a condition that might affect how my body absorbs medication.

I have received a kidney transplant.

Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive a single dose of PF-07817883 and are monitored for pharmacokinetics and safety

5 days

In-patient stay at clinic for 5 nights and 6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28-35 days

Follow-up phone call or CRU visit if needed

What Are the Treatments Tested in This Trial?

Interventions

• PF-07817883

Trial Overview The study tests how PF-07817883, a potential treatment for Coronavirus, is processed in the body across different levels of kidney health. It involves one dose of medication followed by blood sample collection over several days within a controlled clinical setting.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Moderate renal impairment

Group II: Cohort 2 Experimental Treatment 1 Intervention

Severe renal impairment

Group III: Cohort 1 Experimental Treatment 1 Intervention

No renal impairment

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study of 650 HIV-1-infected adults on tenofovir-containing therapy, 55% experienced rapid kidney function decline (RKFD), but only 2% progressed to stage 3 chronic kidney disease (CKD) over a median follow-up of 54 weeks.

Older age and lower baseline kidney function significantly increased the risk of RKFD, with each 10-year increase in age raising the risk by 70%, while women were found to have nearly four times the risk of developing stage 3 CKD compared to men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of stage 3 chronic kidney disease and progression on tenofovir-based regimens. Zachor, H., Machekano, R., Estrella, MM., et al.[2022]

Mycophenolate mofetil (MMF) combined with prednisone significantly reduced urine protein levels and increased serum albumin in patients with refractory nephrotic syndrome, with all patients having minor lesions achieving clinical remission.

The treatment was generally safe, with manageable side effects; however, one patient had to withdraw due to decreased hemoglobin, while renal function remained stable throughout the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mycophenolate mofetil in the treatment of primary nephrotic syndrome]. Zhao, M., Chen, X., Chen, Y., et al.[2016]

In a study of 3520 HIV-infected individuals, switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) resulted in improved estimated glomerular filtration rate (eGFR), particularly in those with lower baseline eGFR levels.

The switch to TAF also led to a decrease in urine protein-to-creatinine ratio (UPCR), indicating reduced proteinuria, which suggests better renal health in patients with renal dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Renal Function After Switching From TDF to TAF in HIV-Infected Individuals: A Prospective Cohort Study. Surial, B., Ledergerber, B., Calmy, A., et al.[2022]

Combining valsartan with clopidogrel and leflunomide significantly reduced proteinuria in patients with progressive IgA nephropathy, with reductions of 62.35% and 69.47% in the respective treatment groups after 24 months.

The combination treatment was associated with minimal adverse reactions and improved renal function compared to valsartan alone, suggesting it could be a safer and more effective option for managing IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valsartan combined with clopidogrel and/or leflunomide for the treatment of progressive immunoglobulin A nephropathy. Cheng, G., Liu, D., Margetts, P., et al.[2018]

In a review of 65 HIV patients at a specialized clinic, tenofovir (TDF) toxicity was the most common reason for referral, but only 13.2% of patients needed to stop the medication immediately, indicating that TDF can often be continued safely with proper monitoring.

The clinic also highlighted that optimizing blood pressure control was a key outcome, suggesting that hypertension is an important but often overlooked factor contributing to renal dysfunction in HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating presentations and outcomes of a joint HIV-renal clinic. Scott, J., Williams, D.[2018]

In a study of 14,477 adult HIV patients, atazanavir (ATV) was not significantly associated with an increased risk of nephrolithiasis compared to other protease inhibitors (PIs), suggesting its safety in this regard.

When comparing ATV to PI-free regimens, there was a positive association with nephrolithiasis in the commercial insurance database, but not in the Medicaid database, indicating variability that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephrolithiasis and renal failure among patients exposed to atazanavir, other PIs and PI-free regimens. Nkhoma, E., Kumar, M., Hines, P., et al.[2018]

In a study of 38 patients with HIV-associated nephropathy, adding corticosteroids to antiretroviral therapy significantly improved kidney function (measured by eGFR) over 2 years compared to those on antiretroviral therapy alone.

Despite the improvement in kidney function, the group receiving corticosteroids experienced higher mortality, indicating that routine use of corticosteroids cannot be recommended without further research to identify which patients might benefit safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of add-on corticosteroids on renal outcomes in patients with biopsy proven HIV associated nephropathy: a single centre study from South Africa. Wearne, N., Swanepoel, CR., Duffield, MS., et al.[2020]

In a study of 286 adults who switched from TDF-based antiretroviral therapy to ABC/3TC, renal function improved significantly, with serum creatinine levels decreasing and estimated glomerular filtration rate (eGFR) increasing over 12 months.

Viral suppression remained effective throughout the switch, with over 93% of patients maintaining a plasma viral load of less than 50 copies/mL, regardless of whether they were taking atazanavir or another third drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a switch from tenofovir- to abacavir-based antiretroviral therapy, with or without atazanavir, on renal function. Guillemi, SA., Ling, SH., Dahlby, JS., et al.[2018]

Bortezomib shows promise in lowering donor-specific antibody levels and improving graft survival when administered before or shortly after kidney transplantation, based on recent studies.

Its effectiveness as a treatment for antibody-mediated rejection post-transplant is still uncertain, indicating a need for more randomized trials to establish its long-term success and optimal timing for administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bortezomib in kidney transplantation. Shah, N., Meouchy, J., Qazi, Y.[2018]

In a study of 311 patients with IgA nephropathy, corticosteroids combined with cyclophosphamide or leflunomide showed significant improvements in kidney function and protein levels compared to corticosteroids alone or with ACEI/ARB.

Complete remission rates were highest in the corticosteroid plus cyclophosphamide (41%) and leflunomide (52.2%) groups, indicating that these combinations may enhance treatment efficacy, although predictors for complete remission included lower proteinuria and less tubular atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effectiveness of cyclophosphamide, leflunomide, corticosteroids, or conservative management alone in patients with IgA nephropathy: a retrospective observational study. Chen, S., Yin, Q., Ren, S., et al.[2023]

Atazanavir, a new HIV protease inhibitor known for its favorable side effects and once-daily dosing, was associated with acute renal failure in a young man, marking a significant safety concern.

The renal biopsy revealed acute interstitial nephritis, which is the first documented case of this condition linked to atazanavir, highlighting the need for monitoring renal function in patients receiving this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute interstitial nephritis associated with atazanavir, a new protease inhibitor. Brewster, UC., Perazella, MA.[2015]

In a study of 741 HIV-infected women, those taking Tenofovir disoproxil fumarate (TDF) with the boosted protease inhibitor lopinavir/ritonavir (LPV/r) experienced significantly more renal events compared to those taking TDF with nevirapine (NVP), with an odds ratio of 3.12.

While the overall incidence of renal events was low (3.2%), higher baseline HIV-1 RNA levels and lower creatinine clearance were identified as risk factors for developing renal insufficiency that required treatment modification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine. Mwafongo, A., Nkanaunena, K., Zheng, Y., et al.[2022]

In a study of 399 HIV-infected patients, proximal renal tubular dysfunction (PRTD) was found to be associated with cumulative exposure to tenofovir (TDF) and atazanavir, indicating a significant risk factor for kidney issues in these patients.

The analysis revealed that even after discontinuing TDF treatment, the risk of PRTD remained high, suggesting potential long-term effects on kidney function in individuals receiving antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased risk of abnormal proximal renal tubular function with HIV infection and antiretroviral therapy. Dauchy, FA., Lawson-Ayayi, S., de La Faille, R., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06679140

NCT06679140 | A Study to Learn About ... Failure to submit primary and secondary outcomes ... renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.

2. pfizer.com pfizer.com/sites/default/files/plsr-studies/C4671028%20Plain%20Language%20Study%20Results%20Summary%20%28PLSRS%29%20Phase%201%20PK%20Primary%20Endpoint.pdf

Clinical Study Results Renal Impairment Either on Hemodialysis or Not on. Hemodialysis]. Date(s) of this. Report: 09 April 2024. Page 2. – Thank You –. If you ...

3. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.3c02469

A Second-Generation Oral SARS-CoV-2 Main Protease ... (6) However, a small percentage of patients find themselves unable to take this drug at present, such as those who have extreme renal impairment and those whose ...

4. contagionlive.com contagionlive.com/view/pfizer-launched-phase-3-trial-for-ibuzatrelvir-a-new-oral-antiviral-for-covid-19-treatment

Pfizer Launched Phase 3 Trial for Ibuzatrelvir, New Oral ... Secondary endpoints will track the incidence of cardiovascular, renal, and pulmonary complications, as well as signs of Long COVID up to 24 ...

5. pfizermedical.pfizerpro.com pfizermedical.pfizerpro.com/api/vc/en/medical/assets/0f98ccb4-08bb-46d6-abfe-3a89b62dc8fc/Ibuzatrelvir%20Phase%202b%20Study%20results-updated%20poster%20%281%29.pdf

results - Pfizer Medical Information No information is available for this page.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06586216

NCT06586216 | A Study to Learn How Renal Impairment ... The purpose of the study is to learn about: how PF-07817883 is processed in the body of adult participants. the safety of PF-07817883. These participants will ...

7. withpower.com withpower.com/trial/phase-1-covid-19-8-2024-5d821

PF-07817883 for Kidney Failure · Info for Participants The provided research does not contain safety data for PF-07817883 (Ibuzatrelvir) in treating kidney failure. The studies focus on other drugs like ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11345836/

A Second-Generation Oral SARS-CoV-2 Main Protease ... PF-07817883 (9) has been nominated as a clinical candidate for the treatment of COVID-19 and has entered clinical trials (NCT05580003, NCT05799495). Results ...