RECRUITING

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

Conditions

Kidney Transplant; Complications Finerenone Cardiovascular Outcomes Albuminuria eGFR decline Congestive Heart Failure Kidney biopsy Functional MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-23

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06059664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). * 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	* 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

Inclusion Criteria

Exclusion 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).
* 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

* 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

Contacts and Locations

Study Contact

Amy Mottl, MD, MPH

CONTACT

919-445-2641

amy_mottl@med.unc.edu

Sara Kelley, MPH

CONTACT

919-445-2658

sara_kelley@med.unc.edu

Principal Investigator

Amy Mottl, MD, MPH

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Prabir Roy-Chaudhury, MD, PhD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

UNC Eastowne Kidney Transplant Clinic

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Amy Mottl, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill
Prabir Roy-Chaudhury, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-23

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2024-04-23

Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Kidney Transplant; Complications