Belumosudil (Rezurock®) to prevent kidney scarring in new kidney transplant recipients

You may qualify if

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Receiving a first or second kidney, except those whose first kidney transplant was lost during year 1 due to rejection or recurrent disease
• Male or female, aged ≥18 to ≤75
• Women of child bearing potential who have a negative serum pregnancy test prior to treatment
• Women of child bearing potential (including perimenopausal women who have had a menstrual period within the previous 1 year) who agree to use 2 forms of effective birth control regimen (at least one of which is a barrier method) throughout the study period and for 6 weeks following the end of the study or the last dose of mycophenolic acid, whichever comes first.
• Sexually active male patients who agree to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment with mycophenolic acid.
• Panel of reactive antibodies (PRA) <80% based on the most recent PRA results that are closest to the date of transplant
• Able to take oral medication
• Agreement to adhere to Lifestyle Considerations throughout study duration (refraining from consumption of grapefruit or grapefruit juice; stopping anticoagulation therapy one week prior through one week post-kidney biopsy procedure; agree to follow FDA guidelines regarding contraception while using mycophenolic acid)

You can't join if

• Transplantation of any organ other than kidney
• Living donor kidney recipients having a 6-antigen match with their donor or a 0-antigen mismatch
• Planned use of non-calcineurin inhibitor immunosuppression maintenance therapy (eg, belatacept)
• Patients with primary focal segmental glomerulosclerosis
• Recipients of en-bloc kidneys
• Patients who have received or are expected to receive alemtuzumab
• Presence of any donor-specific antibody observed during the current or historical crossmatch assessment
• Presence of primary (or familial) dyslipidemia
• Presence of an increased QTc interval > 480 ms on screening ECG, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
• Patients with a history of CABG, cardiac stent placement, or MI within 1 year prior to enrollment
• Patients taking high intensity statin therapy (ie, atorvastatin 40 or 80mg, rosuvastatin 20-40mg)
• Diagnosed with severe liver disease, including abnormal liver enzymes greater than 3 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal.
• Diagnosed with any past or present malignancies except squamous or basal cell carcinoma of the skin excised prior to randomization.
• Diagnosed with active acute or chronic infection, or febrile illness, including absolute neutrophil count less than 1.5 K/µL that, in the Principal Investigator's opinion, would impact the patient's safety or any assessments of this study
• Diagnosed with a genetic disease that leads to excessive bleeding (eg, hemophilia A or factor VIII deficiency, hemophilia B or factor IX deficiency, and von Willebrand disease), genetic or acquired disease that leads to excessive clotting (eg, anti-phospholipid syndrome, factor V Leiden thrombophilia, factor II mutation), or a medical condition requiring uninterrupted long-term systemic anticoagulation after transplantation, which would interfere with obtaining biopsies.
• Patient with platelet count less than 50 K/µL.
• Ever diagnosed with Post-Transplant Lymphoproliferative Disorder (PTLD) if a previous kidney transplant was received
• Use of any investigational drug during the 4 weeks prior to enrolling in this study
• Women of child bearing potential who are breastfeeding
• Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female participants must have experienced 12 consecutive months of amenorrhea.
• Men who are sexually active but do not practice reliable birth control.
• Known allergic reactions to components of REZUROCK®, specifically belumosudil mesylate, microcrystalline cellulose, hypromellose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide or yellow iron oxide.
• Any participant whose surgeon expects they will not perform a baseline biopsy pre- or post-reperfusion of the transplanted organ
• Presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements