The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study (NCT06059664) | Clinical Trial Compass
RecruitingPhase 2
The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
United States100 participantsStarted 2024-04-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 feasibility study testing finerenone in kidney transplant recipients, does it mean researchers are mainly checking whether the trial design works rather than proving the drug is effective — and what does that mean for what I might or might not gain by joining?
2The trial includes an optional kidney biopsy substudy — what would that biopsy involve, how would it be scheduled around my transplant care, and is it something you'd recommend I consider given my current kidney health?
3Finerenone is currently approved for use in chronic kidney disease related to diabetes, but not specifically for transplant recipients — are there any known risks or interactions with my anti-rejection medications that we should talk through before I'd consider this trial?
4Given that this study is still in a feasibility phase, would you recommend I wait to see if a larger main trial opens, or could there be value in discussing enrollment now based on where I am in my transplant recovery?
5Are there standard-of-care treatments or monitoring approaches for post-transplant kidney complications that I should be comparing against before deciding whether a trial like this makes sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial
Timeframe: Up to 3 months after launching the full study protocol
2
Feasibility of recruitment to the kidney biopsy substudy: Total number of participants who were eligible and enrolled in the kidney biopsy substudy
Timeframe: Up to 3 months after launching the full study protocol