150 Participants Needed

Finerenone for Kidney Transplant Recipients

AM
JN
SK
Overseen BySara Kelley, MPH
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as spironolactone, eplerenone, sacubitril/valsartan, potassium-sparing diuretics, and some blood pressure medications, at least 2 weeks before screening. You also need to stop using certain enzyme-affecting drugs at least 7 days before randomization.

What data supports the effectiveness of the drug Finerenone for kidney transplant recipients?

Finerenone has been shown to improve kidney and heart health in patients with chronic kidney disease and type 2 diabetes, suggesting it may help protect kidney function in other conditions as well.12345

How is the drug Finerenone unique for kidney transplant recipients?

Finerenone is unique because it is a non-steroidal mineralocorticoid receptor antagonist, which means it works differently from traditional immunosuppressive drugs used in kidney transplants that often involve steroids or calcineurin inhibitors. This could potentially reduce the side effects associated with these other treatments.678910

Research Team

AM

Amy Mottl, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

PR

Prabir Roy-Chaudhury, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

I received a kidney transplant between 1 and 10 years ago.
My kidney transplant is functioning well, as per my doctor's assessment.
Females of reproductive age must have a negative pregnancy test prior to enrollment and agree to use an intrauterine device, implant or combined oral contraceptive with a physical barrier (e.g., condom) throughout the study period and for 8 weeks following the last intervention dose.
See 6 more

Exclusion Criteria

UACR >3500 mg/g at screening. This may be reassessed if one of the three first morning urine samples is >3500 mg/g at the screening visit
Known hypersensitivity to the study treatment
I need treatment with a steroidal MRA.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone or placebo with dose titration based on potassium levels

12 months
Regular visits for dose titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Kidney Biopsy Substudy

Participants undergo kidney biopsy before randomization and at the end of active treatment

12 months

Functional MRI Substudy

Participants undergo fMRI before randomization and at the end of active treatment

12 months

Treatment Details

Interventions

  • Finerenone
  • Placebo
Trial OverviewThis 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.
Participant Groups
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.

Finerenone is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Kerendia for:
  • Chronic kidney disease associated with type 2 diabetes
🇪🇺
Approved in European Union as Kerendia for:
  • Chronic kidney disease associated with type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Bayer

Industry Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

In a study of 5,674 patients with chronic kidney disease and type 2 diabetes, finerenone significantly reduced the risk of kidney and cardiovascular complications, regardless of baseline HbA1c levels or insulin use.
The treatment was well-tolerated, with similar rates of adverse events between finerenone and placebo groups, indicating its safety profile, particularly with low discontinuation rates due to hyperkalemia.
Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study.Rossing, P., Burgess, E., Agarwal, R., et al.[2023]
In the FIDELIO-DKD trial, 21.4% of patients treated with finerenone experienced mild hyperkalemia compared to 9.2% in the placebo group, indicating a higher risk of elevated potassium levels with finerenone.
Despite the increased risk of hyperkalemia associated with finerenone, effective monitoring and management strategies were implemented, which helped minimize its impact and support the safe clinical use of the medication.
Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial.Agarwal, R., Joseph, A., Anker, SD., et al.[2023]
In a study of 13,026 patients with chronic kidney disease (CKD) and type 2 diabetes, finerenone showed similar efficacy in reducing cardiovascular and kidney-related events in Hispanic patients compared to non-Hispanic patients, with a notable 20% reduction in cardiovascular events for those on finerenone.
Finerenone also significantly reduced urinary albumin-to-creatinine ratio (UACR) by 32% at month 4 in both Hispanic and non-Hispanic patients, indicating its effectiveness in improving kidney function, while maintaining a similar safety profile across both groups.
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis.Rosas, SE., Ruilope, LM., Anker, SD., et al.[2023]

References

Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. [2023]
Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. [2023]
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. [2023]
Finerenone in diabetic kidney disease: A systematic review and critical appraisal. [2022]
Finerenone Dose-Exposure-Serum Potassium Response Analysis of FIDELIO-DKD Phase III: The Role of Dosing, Titration, and Inclusion Criteria. [2022]
Medication errors and adverse drug events in kidney transplant recipients: incidence, risk factors, and clinical outcomes. [2022]
Steroid Avoidance or Withdrawal Regimens in Paediatric Kidney Transplantation: A Meta-Analysis of Randomised Controlled Trials. [2022]
Once-daily extended-release versus twice-daily standard-release tacrolimus in kidney transplant recipients: a systematic review. [2022]
Novel immunosuppressive agents in kidney transplantation. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A matched cohort pharmacoepidemiological analysis of steroid free immunosuppression in renal transplantation. [2009]