A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Belumosudil for the Abrogation of Interstitial Fibrosis and Tubular Atrophy in de Novo Kidney Transplant Recipients

This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of belumosudil (brand name- REZUROCK®) on the background of standard immunosuppression will prevent fibrosis in the kidney transplant. Interstitial expansion is the precursor of interstitial fibrosis and graft loss. The hypothesis underlying the study is that abgrogating the fibrogenic effects of the RhoA pathway with belumosudil will reduce structural damage in transplanted kidneys and possible subsequent transplant failure.

CT.gov Identifier

NCT06751602

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

N/A

Study Contact Information

N/A

Recruiting

Study Details

Diseases

Autosomal Dominant Tubulointerstitial Kidney Disease (ADTKD)

Study Drug

Pregabalin & Placebo

Belumosudil 200 mg QD

Genes

UMOD

Study Dates

Sep 2025 - Dec 2027

Sex

Female & Male

Age

18 - 75 Years

Inclusion and Exclusion Criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Protocol Summary

Study Locations

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