What side effects are associated with this type of intervention?

Common treatments for kidney failure, particularly those involving investigational drugs and molecularly targeted agents, can have a range of side effects. These include nephrotoxicity, acute renal failure, and electrolyte imbalances. Specific drugs like carfilzomib and dasatinib have been associated with acute kidney injury and thrombotic microangiopathy. Additionally, treatments such as PCSK9 inhibitors, while generally well-tolerated, may require careful monitoring in patients with severe renal impairment. Other side effects across various treatments can include hypertension, fatigue, diarrhea, and increased risk of infections.

What prior FDA approvals exist?

Several FDA-approved drugs have been used to treat conditions related to kidney failure, particularly in the context of renal cell carcinoma. Tyrosine kinase inhibitors such as sorafenib, sunitinib, and vandetanib have been approved for their efficacy in treating metastatic renal cell carcinoma, even in patients with renal impairment. Additionally, immunotherapy agents like nivolumab and pembrolizumab have been approved for advanced renal cell carcinoma, offering new avenues for treatment. These drugs have been studied for their safety, tolerability, and pharmacokinetics in patients with varying degrees of renal function, ensuring their applicability in this patient population.

What other types of research exist?

Promising novel alternatives for kidney failure patients include: 1) TRF-budesonide, which has shown efficacy in reducing proteinuria and stabilizing eGFR in IgA nephropathy patients, though it has notable glucocorticoid-related adverse events. 2) Calcineurin inhibitors (CNIs) like cyclosporine and tacrolimus, which have demonstrated higher rates of complete remission of proteinuria in combination with glucocorticoids. 3) Cabozantinib, which is being evaluated in phase III trials for renal cell carcinoma and may offer a new therapeutic option. 4) Lapatinib, an EGFR/HER2 tyrosine kinase inhibitor, which is under investigation for various tumors including renal cell cancer. These alternatives are in various stages of clinical trials and may provide new options for kidney failure treatment in the near future.

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PPAR Agonist

Saroglitazar for Kidney Failure

Q: What is the mechanism of action of this treatment?

Common treatments for kidney failure include plasmapheresis, immunosuppressive therapy, and glucocorticoids. Plasmapheresis works by removing circulating antibodies that can cause kidney damage, which is crucial for conditions like anti-GBM disease. Immunosuppressive therapy, such as cyclophosphamide, reduces the immune system's activity to prevent further kidney damage. Glucocorticoids, like prednisone, reduce inflammation and immune response, helping to preserve kidney function. These treatments are vital for kidney failure patients as they address the underlying causes of kidney damage, potentially slowing disease progression and improving outcomes.

Phase 1

Waitlist Available

Led By Dr. Eric Lawitz, MD

Research Sponsored by Zydus Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Ability to swallow and retain oral medication

Laboratory test values for severe renal impairment subjects must be clinically acceptable to the Investigator and meet all of the following parameters at screening: ALT value ≤ 3 × ULN, AST value ≤ 3 × ULN, Absolute neutrophil count (ANC) ≥ 750/mm3, Platelets ≥ 50,000/mm3

Must not have

For healthy renal function subjects, QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec, confirmed by repeat measurement. In renal impaired subjects QTcF > 500 msec, confirmed by repeat measurement; no second or third degree AV block

Group 2 (Normal renal function) subjects, who have a history of renal disease or renal injury as indicated by an abnormal BUN or creatinine at screening or Day-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before dosing on day 1 through day 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Saroglitazar Magnesium, a medication that helps control blood sugar and fat levels, in people with severe kidney problems and those with normal kidney function.

Who is the study for?

Adults aged 18-80 with either normal kidney function or severe renal impairment (not on dialysis, eGFR <30) can join. They must be able to take oral meds, have a BMI of 18-48 kg/m2, and use effective contraception if applicable. Exclusions include unstable medical conditions, recent malignancies except certain cancers, drug/alcohol abuse, HIV/HBV/HCV infection, major surgeries within specific timeframes.

What is being tested?

The study is testing Saroglitazar Magnesium's effects in people with different levels of kidney health. It's an open-label Phase 1 trial where participants are openly given the medication to understand how it behaves in bodies with normal vs severely impaired kidneys.

What are the potential side effects?

While not specified here, typical side effects for similar medications may include digestive issues like nausea or diarrhea; changes in blood sugar levels; fatigue; possible liver enzyme alterations; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow and keep down pills.

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My kidney function tests and blood counts are within acceptable ranges.

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I am between 18 and 80 years old.

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My kidney function is normal, with an eGFR of 90 or above.

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I am between 18 and 80 years old.

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I can swallow and keep down pills.

Exclusion Criteria

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

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My heart's electrical activity is within a safe range, confirmed by tests.

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I have normal kidney function but a history of kidney issues.

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I am currently on treatment for an active infection.

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I have not had a blood transfusion in the last 2 weeks.

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I have not had major surgery in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before dosing on day 1 through day 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before dosing on day 1 through day 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and before dosing on day 1 through day 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC from time zero to infinity (AUC0-∞)

AUC from time zero to the last quantifiable concentration (AUC0-t)

CL/F

+4 more

Secondary study objectives

Incidence of AEs

Unbound Fraction

Unbound concentration

+1 more

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: Group 2Experimental Treatment1 Intervention

Subjects (Normal renal function eGFR ≥90) will be matched according to age (± 10 years), sex, and weight (± 20 kg) with participants in Group 1 (Severe renal impairment not on HD) on a one to one basis based on demographic characteristic. Here, 8 participants will be administered single dose of 2 mg Saroglitazar Magnesium and 8 participants will be administered single dose of 4 mg Saroglitazar Magnesium.

Group II: Group 1Experimental Treatment1 Intervention

Subjects in severe renal impairment group will be enrolled and dosed consecutively (i.e. first 8 subjects of group 1 will receive 2 mg dose, followed by another 8 subjects who will receive 4 mg dose).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saroglitazar magnesium

2019

Completed Phase 1

~40

0 / 11Eligibility 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

Common treatments for kidney failure include plasmapheresis, immunosuppressive therapy, and glucocorticoids. Plasmapheresis works by removing circulating antibodies that can cause kidney damage, which is crucial for conditions like anti-GBM disease. Immunosuppressive therapy, such as cyclophosphamide, reduces the immune system's activity to prevent further kidney damage. Glucocorticoids, like prednisone, reduce inflammation and immune response, helping to preserve kidney function. These treatments are vital for kidney failure patients as they address the underlying causes of kidney damage, potentially slowing disease progression and improving outcomes.

Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study.