Recruiting
Phase 2

Finerenone

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06059664

Conditions

Kidney Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Finerenone Oral Tablet

Placebo

Study Details

Brief summary:

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.

Conditions

Kidney Transplant; Complications

Study ID

NCT06059664

Start date

Apr 23, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Clinical Trial Inclusion Criteria:

  • Adult kidney transplant recipients ≥ 18 years
  • 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
  • Preserved kidney allograft function defined as an eGFR ≥ 25 mL/min/1.73 m
  • Urine albumin:creatinine ratio (UACR) ≥30 ug/mg
  • Ability of the participant, or their legally authorized representative, to provide informed consent
  • Contraceptive requirements:
  • Women of non-childbearing potential do not need to undergo pregnancy testing or agree to use adequate contraception. Non-childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, oophorectomy or postmenopausal females (amenorrhea for 12 months without an alternative medical cause). A single high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state.
  • Women of childbearing potential can only be included if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception during the study and until 8 weeks after the last study intervention dose. Adequate contraception is defined as an intrauterine device, implant or combined oral contraceptive with a physical barrier (e,g., condom).

Additional Inclusion Criteria for Kidney Biopsy Sub-study:

  • Willingness to undergo research study biopsies at screening and following the 12 month treatment period
  • Ability to safely discontinue antiplatelet or anticoagulant treatments
  • No known intrinsic bleeding diathesis
  • Hemoglobin >9.0 g/dL; Platelets > 100,000; International Normalised Ratio (INR) <1.4 on the day of kidney biopsy
  • Body mass index <40
  • Blood pressure controlled on the day of biopsy to <160/90

Medical Condition Exclusion Criteria:

  • Documented recurrent lupus nephritis, ANtineutrophilic Cytoplasmic Antibody (ANCA) vasculitis, membranoproliferative glomerulonephritis (including C3 glomerulopathy)
  • History of solid organ transplantation other than kidney
  • Acute kidney injury requiring dialysis within 6 months prior to screening
  • Uncontrolled hypertension with a sitting Systolic Blood Pressure (SBP) ≥180 mmHg or Diastolic Blood Pressure (DBP) ≥100 mmHg
  • Any indication for treatment with a steroidal MRA
  • 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
  • CV event within 3 months prior to screening (heart failure requiring acute care, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting)
  • Elective percutaneous coronary intervention within 1 month prior to screening
  • Known hypersensitivity to the study treatment
  • Addison's disease
  • Hepatic insufficiency classified as Child-Pugh C
  • Pregnancy, breast feeding or intention to become pregnant

Concomitant Therapies Exclusion Criteria:

  • Concomitant therapy with spironolactone, eplerenone, sacubitril/valsartan combination, or potassium-sparing diuretic which cannot be discontinued at least 2 weeks prior to screening
  • Simultaneous use of Angiotensin-Converting Enzyme Inhibitors (ACEI) and Angiotensin Receptor Blockers (ARB), without being able to discontinue one of these at least 2 weeks prior to screening
  • Use of potent CYP3A4 inhibitors or inducers (to be stopped at least 7 days before randomization).

Other Exclusion Criteria:

  • Participation in the MRI Study is excluded for certain pacemakers, electronic implants, shrapnel of the eye and certain types of aneurysm clips.
  • Any other history, condition, or therapy which could, in the opinion of the investigator, affect compliance with the study treatment and procedures
  • Close affiliation with the investigational site, investigators or staff
  • Simultaneous participation in another interventional trial within 30 days prior to randomization

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Finerenone Oral Tablet

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

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.

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 ]
  • Feasibility of recruitment to the kidney biopsy substudy: Total number of participants who were eligible and enrolled in the kidney biopsy substudy [ Time Frame: Up to 3 months after launching the full study protocol ]

Central Contacts and Locations

Central contacts

Amy Mottl, MD, MPH

919-445-2641amy_mottl@med.unc.edu

Sara Kelley, MPH

919-445-2658sara_kelley@med.unc.edu

Locations

UNC Eastowne Kidney Transplant Clinic

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Sara Kelley, MPH

919-445-2658sara_kelley@med.unc.edu

Sora Lee, BA

919-445-2657leesora@email.unc.edu

Principal Investigator:

Amy Mottl, MD, MPH

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 14, 2026

Last verified

Feb, 2026

Keywords

  • Finerenone
  • Cardiovascular Outcomes
  • Albuminuria
  • eGFR decline
  • Congestive Heart Failure
  • Kidney biopsy
  • Functional MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-14.