Remibrutinib for Renal Disease

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Immunosuppressants, Immunomodulators, others

Disqualifiers: Malignancy, Infectious disease, Bone marrow failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 72 hours postdose

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of remibrutinib, a new treatment, for people with severe kidney problems. The goal is to determine the right dosage for those with kidney issues. Participants will include individuals with significant kidney impairment and healthy individuals for comparison. Those who have not needed dialysis and have stable kidney function might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking prescription drugs, over-the-counter medications, or herbal supplements at least 2 weeks before the trial starts. If you use cannabis or marijuana, you must stop 4 weeks before the trial begins.

Is there any evidence suggesting that remibrutinib is likely to be safe for humans?

Research has shown that remibrutinib has been safe in past studies. For instance, people with chronic spontaneous urticaria (a skin condition) tolerated it well for up to 52 weeks. Another study found it was safe for people with Sjögren's syndrome (an autoimmune disorder) over 24 weeks. These studies did not identify any major safety issues.

However, this current trial is in an early stage. The main goal is to determine if the treatment is safe for people with severe kidney problems. While remibrutinib has been safe in other conditions, its safety in this specific group is still under investigation. Researchers will closely monitor participants to ensure their safety during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for renal disease?

Most treatments for renal disease focus on controlling blood pressure and managing symptoms. But remibrutinib works differently, targeting the Bruton's tyrosine kinase (BTK) pathway, which plays a crucial role in immune cell signaling. This unique mechanism promises to address the underlying causes of renal impairment rather than just the symptoms. Researchers are excited about remibrutinib because it could potentially offer a more direct and effective approach to treating severe renal impairment.

What evidence suggests that remibrutinib might be an effective treatment for renal disease?

This trial will evaluate the effects of remibrutinib in participants with severe renal impairment and matched healthy participants. Studies have shown that remibrutinib can help with certain health conditions. For example, it significantly improved symptoms in patients with Sjögren's syndrome, a disease affecting the immune system. Remibrutinib blocks a protein that can cause inflammation and other symptoms. It has shown positive effects in conditions involving cells like mast cells and basophils, which are part of the immune response. Although specific data for kidney disease is not yet available, these findings suggest potential benefits due to its effects on the immune system. ^{1 4 6 7 8}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with severe renal impairment, matched by healthy participants with normal kidney function. Participants must be non-smokers or light smokers, have stable vital signs and no significant recent illnesses or use of certain medications. They cannot have a history of serious heart issues, infections, cancer in the past 5 years, or be on dialysis.

Inclusion Criteria

Seated vital signs must be within specified ranges at Screening and Baseline

I match another participant in age, weight, race, ethnicity, and sex.

My overall health is good based on recent medical exams and tests.

Exclusion Criteria

I haven't been seriously ill in the last 2 weeks.

Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever is longer

History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remibrutinib for pharmacokinetic evaluation over multiple doses

Up to 72 hours postdose

Multiple visits for dosing and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Follow-up visits to monitor adverse events

What Are the Treatments Tested in This Trial?

Interventions

• Remibrutinib

Trial Overview The study tests remibrutinib's safety and how it's processed in the body (pharmacokinetics) in people with severe kidney problems compared to those without. It aims to establish proper dosing guidelines for patients with impaired renal function.

How Is the Trial Designed?

Group I: Participants with severe renal impairment Experimental Treatment 1 Intervention

Participants with severe renal impairment will receive remibrutinib

Group II: Healthy participants Experimental Treatment 1 Intervention

Matched healthy participants will receive remibrutinib

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032272

NCT07032272 | A Study to Investigate the ... A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

2. novartis.com novartis.com/clinicaltrials/study/nct06865651

Study of Remibrutinib (LOU064) Efficacy and Safety ... The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003496724003649

Efficacy and safety of remibrutinib, a selective potent oral ... Remibrutinib significantly improved ESSDAI score in patients with SjS over 24 weeks compared with placebo.

4. withpower.com withpower.com/trial/phase-1-renal-insufficiency-6-2025-ff4fe

Remibrutinib for Renal Disease This trial is for adults aged 18-75 with severe renal impairment, matched by healthy participants with normal kidney function. Participants must be non-smokers ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8504815/

Remibrutinib (LOU064): A selective potent oral BTK inhibitor ... Remibrutinib showed encouraging blood and skin PDs with a favorable safety profile, supporting further development for diseases driven by mast cells, basophils, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5641823/

Safety and efficacy of ibrutinib in a patient with severe renal ... Our case showed that ibrutinib can be safely used in patients with severe renal failure under close renal function monitoring.

7. jacionline.org jacionline.org/article/S0091-6749(23)01346-5/fulltext

Remibrutinib demonstrates favorable safety profile and ... Remibrutinib demonstrated a consistent favorable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU. Key ...

8. ard.bmj.com ard.bmj.com/content/83/3/360

Efficacy and safety of remibrutinib, a selective potent oral BTK ... Remibrutinib had a favourable safety profile in patients with SjS over 24 weeks. Remibrutinib induced significant changes in gene expression in blood, and serum ...