The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06059664
Phase
PHASE2
Status
Recruiting
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Conditions

  • Kidney Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone Oral Tablet — DRUG
    Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.
  • Placebo — DRUG
    Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.

Study Details

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.

Key Dates

Start date
Apr 23, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial [ Time Frame: Up to 3 months after launching the full study protocol ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Eastowne Kidney Transplant ClinicChapel HillNorth Carolina27514
Sara Kelley, MPH
[email protected]
919-445-2658
Sora Lee, BA
[email protected]
919-445-2657
Amy Mottl, MD, MPH (PRINCIPAL_INVESTIGATOR)
Prabir Roy-Chaudhury, MD, PhD (PRINCIPAL_INVESTIGATOR)
Elizabeth Kotzen, MD, MSCR (SUB_INVESTIGATOR)
Mark Kleman, DO (SUB_INVESTIGATOR)
Randal Detwiler, MD (SUB_INVESTIGATOR)
Charles Jennette, MD (SUB_INVESTIGATOR)

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By research site
UNC Eastowne Kidney Transplant Clinic· Chapel Hill, NC

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