Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06059664

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-04-14

100

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Clinical Trial

  • 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

Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

UNC Eastowne Kidney Transplant Clinic

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

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Research Team

A

Amy Mottl, MD, MPH

CONTACT

S

Sara Kelley, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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