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New treatment option for Kidney Transplant; Complications
Official title The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
ClinicalTrials.gov ID: NCT06059664
What this study is testing
What is Finerenone Oral Tablet?
Finerenone Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for kidney transplant; complications.
Also referred to as Kerendia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Documented recurrent lupus nephritis, ANtineutrophilic Cytoplasmic Antibody (ANCA) vasculitis, membranoproliferative glomerulonephritis (including C3...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- 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 treatment trial within 30 days prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.