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Mineralocorticoid Receptor Antagonist

Finerenone for Kidney Transplant Recipients

Phase 2

Recruiting

Led By Amy Mottl, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

1 to 10 years post kidney transplantation from a deceased or living donor

Stable kidney allograft function (within 20% baseline eGFR) and based on the clinical judgement of the investigator

Must not have

Any indication for treatment with a steroidal MRA

Addison's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from within 2 weeks before randomization, within 2 weeks before last on study drug visit, up to 12.5 months

Summary

This trial will study the safety and effectiveness of a drug, finerenone, in 150 kidney transplant patients. It will also include two additional studies to further understand the effects.

Who is the study for?

The EFFEKTOR study is for adult kidney transplant recipients who are 1 to 10 years post-transplant with a certain level of protein in their urine and stable kidney function. Participants must agree to use contraception if of childbearing potential, or be confirmed not of childbearing potential.

What is being tested?

This trial tests the safety and effectiveness of finerenone compared to a placebo in people who have received a kidney transplant. It includes special substudies involving kidney biopsies and functional MRI scans before treatment starts and after it ends.

What are the potential side effects?

While specific side effects for finerenone aren't listed here, common ones may include changes in potassium levels, blood pressure alterations, and gastrointestinal symptoms. Side effects will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I received a kidney transplant between 1 and 10 years ago.

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My kidney transplant is functioning well, as per my doctor's assessment.

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My kidney transplant is working well.

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I am an adult who has received a kidney transplant.

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I can make my own medical decisions or have someone who can.

Exclusion Criteria

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

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I need treatment with a steroidal MRA.

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I have Addison's disease.

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I needed dialysis for kidney injury within the last 6 months.

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I have a confirmed diagnosis of lupus nephritis, ANCA vasculitis, or membranoproliferative glomerulonephritis.

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My liver is not working well (severe condition).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from within 2 weeks before randomization, within 2 weeks before last on study drug visit, up to 12.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from within 2 weeks before randomization, within 2 weeks before last on study drug visit, up to 12.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from within 2 weeks before randomization, within 2 weeks before last on study drug visit, up to 12.5 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of recruitment to the kidney biopsy substudy: Total number of participants who were eligible and enrolled in the kidney biopsy substudy

Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial

Secondary study objectives

Adverse Event (AE) related to acute kidney injury

Adverse Event (AE) related to hyperkalemia

Efficacy for albuminuria reduction

+4 more

Other study objectives

Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney fibrosis

Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney oxygenation

Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney perfusion

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FinerenoneExperimental Treatment1 Intervention

Participants in this study arm will receive the study drug Finerenone. Initial Dosing: Dosing regimen of 10 mg or 20 mg once daily (QD), based upon screening eGFR. For eGFR \< 60 mL/min/1.73m\^2, participants will start at 10 mg QD. For eGFR ≥ 60 mL/min/1.73m\^2, participants will start at 20 mg QD. Dose Titration: Dose will be titrated according to potassium levels. For participants initiated at 10mg, the dose will be up titrated to 20 mg if the potassium level measured after 2 weeks is ≤4.8 meq/L and eGFR has not decreased by \>30 percent of the screening visit value. Study drug dosing may be titrated up or down per the below. Potassium level: ≤ 4.8 * If on lower dose, up-titrate to higher dose * If on higher dose, continue on the same dose Potassium level: 4.9-5.5 = continue same dose Potassium level: \>5.5 = withhold study drug and recheck potassium within 3 days. Re-initiate study drug at the 10 mg dose once potassium is ≤4.8 meq/L.

Group II: PlaceboPlacebo Group1 Intervention

Participants in this study arm will receive the placebo comparator. Initial Dosing: Dosing regimen of 10 mg or 20 mg once daily (QD), based upon screening eGFR. For eGFR \< 60 ml/min/1.73m\^2, participants will start at 10mg QD. For eGFR ≥ 60ml/min/1.73m\^2, participants will start at 20 mg QD. Dose Titration: Dose will be titrated according to potassium levels. For participants initiated at 10 mg, the dose will be up titrated to 20 mg if the potassium level measured after 2 weeks is ≤4.8 meq/L and eGFR has not decreased by \>30 percent of the screening visit value. Study drug dosing may be titrated up or down per the table below. Potassium level: ≤ 4.8 * If on lower dose, up-titrate to higher dose * If on higher dose, continue on the same dose Potassium level: 4.9-5.5 = continue same dose Potassium level: \>5.5 = withhold study drug and recheck potassium within 3 days. Re-initiate study drug at the 10 mg dose once potassium is ≤4.8 meq/L.

0 / 10Eligibility criteria met