What side effects are associated with this type of intervention?

Common treatments for kidney failure include dialysis, kidney transplantation, and medications such as immunosuppressants and mineralocorticoid receptor antagonists. Dialysis can cause side effects like low blood pressure, muscle cramps, and infections. Kidney transplantation may lead to complications such as rejection, infections, and cardiovascular issues. Immunosuppressants can increase the risk of infections and certain cancers. Mineralocorticoid receptor antagonists, like finerenone, may cause hyperkalemia and renal impairment. For ROCK2 inhibitors like Belumosudil (KD025), potential side effects could include immunological reactions and transplant tolerance issues, although specific data is limited.

What prior FDA approvals exist?

Belumosudil (KD025) is a ROCK2 inhibitor being studied for its potential to improve transplant tolerance in kidney transplant patients. While the provided context does not mention specific FDA-approved ROCK2 inhibitors for kidney failure, treatments for kidney failure generally include immunosuppressive therapies such as cyclophosphamide, azathioprine, and glucocorticoids, which are used to manage conditions like anti-GBM disease and IgA nephropathy. Additionally, angiotensin receptor blockers (ARBs) like valsartan and ACE inhibitors are commonly used to manage kidney function and reduce proteinuria in various kidney diseases.

What other types of research exist?

Promising novel alternatives to Belumosudil (KD025) for kidney failure patients include SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), which have shown renal protective effects in chronic kidney disease (CKD) patients, and non-steroidal mineralocorticoid receptor antagonists (e.g., finerenone), which have demonstrated benefits in reducing kidney disease progression. Additionally, novel agents like bardoxolone methyl, which targets oxidative stress and inflammation pathways, are also being explored for their potential in treating kidney failure.

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Small Molecule

Immunological Tolerance Therapy for Kidney Transplant Rejection

Phase 1

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if Belumosudil can help kidney transplant patients accept their new kidney without long-term immune-suppressing drugs. It targets patients with partially matched or slightly mismatched donors. The drug works by boosting special immune cells that help the body accept the new kidney.

Who is the study for?

Adults over 18 eligible for kidney and stem cell transplants can join this trial if they have a matched living donor, are not pregnant, agree to use contraception, live near UCLA Medical Center, and have good heart, liver, and lung function. Excluded are those with certain infections or diseases requiring immunosuppression, recent drug abuse history, very high BMI or previous organ transplants.

What is being tested?

The study is testing the safety and effectiveness of belumosudil in improving transplant tolerance when given alongside a combined kidney and hematopoietic stem cell transplant from either a half-matched related donor or an unrelated donor with minimal HLA mismatches.

What are the potential side effects?

Potential side effects of belumosudil may include changes in blood counts leading to increased risk of infection or bleeding. Other risks could involve allergic reactions to the medication as well as possible impacts on liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine impact of treatment regimen on patient and kidney allograft survival

Secondary study objectives

Determine probability of successful withdrawal of immunosuppression

Determine risk of acute and/or chronic graft vs host disease

Determine risk of kidney allograft rejection

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nephrolithiasis

13%

Nausea

13%

Vomiting

13%

Anastomotic ulcer

13%

Somnolence

13%

Pyrexia

13%

Anastomotic ulder

13%

Hypokalemia

13%

Rib Fracture

13%

Fall

13%

Tooth ache

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Immune tolerance in mismatched kidney transplant recipientExperimental Treatment1 Intervention

Our goal is to establish this regimen as a novel, safe and effective approach for induction of transplant tolerance in HLA single haplotype-matched related and HLA mismatched unrelated recipients of combined Hematopoietic Stem Cell Transplant(HSCT)/ Kidney Transplant (KT). Patients will undergo conditioning with rATG and TLI, followed by infusion of hematopoeitic stem cells from the same donor, a triple immunosuppressive regimen, and receive belumosudil following the kidney transplant. Immunosuppression taper will be stopped and/or immunosuppression will be resumed for any of the following conditions: (1) loss of chimerism 2) clinical or pathological evidence of acute rejection and (3) clinical or pathological evidence of graft vs host disease.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure include glucocorticoids, oral alkali drug therapy, and ROCK2 inhibitors like belumosudil (KD025). Glucocorticoids reduce inflammation and immune response, which can help slow the progression of kidney damage. Oral alkali drug therapy helps to neutralize acid in the blood, potentially reducing the risk of kidney failure events. Belumosudil (KD025), a ROCK2 inhibitor, aims to improve transplant tolerance and reduce fibrosis, which is crucial for maintaining kidney function and preventing further damage. These treatments are important for kidney failure patients as they target different aspects of the disease, helping to manage symptoms, slow progression, and improve overall outcomes.

Efficacy and safety of intermittent vs continuous furosemide for heart failure concomitant renal dysfunction: A protocol for systematic review and meta-analysis.Effects of oral alkali drug therapy on clinical outcomes in pre-dialysis chronic kidney disease patients: a systematic review and meta-analysis.Effects of tonifying kidney and strengthen bone therapy on non-dialysis patients with chronic kidney disease-mineral and bone disorder: A protocol for the systematic review and meta-analysis of randomized controlled trials.