Can a cancer drug protect new kidneys from scarring?
NCT ID NCT06751602
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding belumosudil (Rezurock) to standard care can prevent scarring in new kidney transplants. About 40 adults receiving their first or second kidney will be randomly assigned to get the drug or a placebo for a year. The study tracks serious side effects and checks kidney tissue for scarring at 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Belumosudil (also known as Rezurock)
- What this could lead to
- If it works, this could point toward a way to prevent kidney scarring and extend transplant life without increasing rejection risk.
- What could go wrong
- This is a small, early-phase trial (40 people) testing a drug already approved for another condition. It may not show benefit, and side effects could occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Research Institute
Houston, Texas, 77030, United States
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