Is NCT06059664 recruiting in Chapel Hill, NC?

Yes, NCT06059664 is currently recruiting participants at its Chapel Hill, NC location. This kidney transplant; complications clinical trial is actively enrolling qualified participants.

Is participation in this Chapel Hill clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Kidney Transplant; Complications Clinical Trial in Chapel Hill, NC

Q: How do I join the kidney transplant; complications clinical trial in Chapel Hill?

To join this clinical trial in Chapel Hill, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Kidney Transplant; Complications Study in Chapel Hill

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.

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chapel Hill?

Yes, this clinical trial (NCT06059664) has an active research site in Chapel Hill, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kidney Transplant; Complications Treatment Options in Chapel Hill, NC

If you're searching for kidney transplant; complications treatment options in Chapel Hill, NC, this clinical trial (NCT06059664) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chapel Hill research site is actively enrolling participants for this clinical trial. You'll receive care from experienced kidney transplant; complications specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kidney transplant; complications clinical trials near you to find additional studies recruiting in your area.

Kidney Transplant; Complications Clinical Trial in Chapel Hill, NC

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