RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Objective 1: To determine the feasibility of recruitment of KTRs to a clinical trial of finerenone with embedded kidney biopsy study."
  • "Such information is deemed critical in helping to determine whether future, larger trials of KTRs are indicated, and whether kidney biopsy could be useful for stratifying participants (eg. based on the presence or degree of interstitial fibrosis)."
  • "Kidney biopsy also yields valuable information helpful to clinical decisions in caring for KTRs but does come with some risks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests finerenone in adults who had a kidney transplant 1 to 10 years ago. It compares the drug with a placebo (a pill with no active drug) to learn how safe it is, how well people tolerate it, and how well it works. Smaller groups will also have kidney tissue samples taken or MRI scans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have received a kidney from a living or deceased donor 1 to 10 years ago.
  • Have stable kidney function, with test results within 20% of your usual level, as judged by the study doctor.
  • Have an eGFR (a measure of how well your kidney filters blood) of at least 25.
  • Have a urine albumin-to-creatinine ratio (a urine protein test) of at least 30 ug/mg.
  • You or your legal representative must be able to give consent to join.
  • If you can become pregnant, have a negative pregnancy test and use the required birth control during the study and for 8 weeks after the last dose.
  • For the kidney tissue sample group, agree to samples before treatment and after 12 months. You must be able to safely stop blood-thinning medicines and have no known bleeding disorder.
  • For the tissue sample group, meet blood count and clotting limits, have a body mass index below 40, and have blood pressure below 160/90 on the sample day.

Who can't join

  • Certain kidney diseases that have returned: lupus nephritis, ANCA vasculitis, or membranoproliferative glomerulonephritis, including C3 disease. These cause kidney inflammation or damage.
  • A transplant of an organ other than a kidney, or sudden kidney injury needing dialysis in the past 6 months.
  • Blood pressure with a top number of 180 or higher or a bottom number of 100 or higher; or urine protein above 3,500 mg/g at screening.
  • Certain heart or blood vessel events in the past 3 months, such as a heart attack, stroke, mini-stroke, lung blood clot, heart failure needing urgent care, or planned heart bypass surgery. A planned procedure to open heart arteries in the past month also excludes you.
  • An allergy to the study treatment, Addison’s disease (too little of certain hormones), severe liver failure, pregnancy, breastfeeding, or plans to become pregnant.
  • Need for a steroid-type mineralocorticoid receptor blocker, such as spironolactone. Certain heart, blood pressure, or water pills and drugs that change how finerenone is broken down must be stopped within the study’s required time limits.
  • For the MRI group only: certain pacemakers, electronic implants, metal fragments in the eye, or certain clips used to treat a bulging blood vessel.
  • Another treatment trial within 30 days before study group assignment; close ties to the study site or staff; or any condition or treatment the study doctor thinks could prevent you from following study instructions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NC