The Methodist Hospital Research Institute
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.
Of the 16,521 adult kidney transplants in 2008, death-censored graft loss occurred in 16% of deceased donor kidneys and 7% of living donor kidneys in the ensuing 5 years and has not largely changed in a decade. A majority of this graft loss is presumed to be from IF/TA, previously termed chronic allograft nephropathy. Various causes of injury to the kidney stimulate inflammatory processes. When the inflammation continues (ie, becomes chronic), changes occur in the kidney structure, specifically in the glomerulus and tubular interstitium which leads to fibrosis and a progressive decline in kidn…
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 form…
Belumosudil 200 mcg oral daily
Placebo (once daily)
Arctuva estimate
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