BMS-986278 for Kidney Failure

No longer recruiting at 7 trial locations

Overseen By Thomas Marbury, Site 0001

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Significant medical condition, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMS-986278 (an experimental drug), to evaluate its effectiveness and safety for individuals with severe kidney problems. Researchers aim to understand how the drug behaves in the bodies of those with serious kidney issues, including individuals requiring regular dialysis, a process that cleans the blood when kidneys do not function properly. The study divides participants into groups based on the severity of their kidney problems. Suitable candidates for this trial include individuals with severe kidney issues, whether they are not yet on dialysis or are already undergoing regular dialysis sessions. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BMS-986278 is likely to be safe for humans?

In the absence of specific safety data for BMS-986278, the study phase provides insight into its safety. As an early-stage study, the treatment is still being tested for safety in humans. Studies at this stage generally focus on assessing how well participants tolerate the treatment and identifying potential side effects.

If the FDA had approved the treatment for other conditions, it might offer some reassurance about its safety. However, without specific data or past approvals, the safety of BMS-986278 remains under evaluation, and trial participants will help gather this crucial information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney failure, which often involve dialysis or transplantation, BMS-986278 offers a novel approach by potentially targeting specific biochemical pathways involved in kidney disease progression. Researchers are excited about this treatment because it utilizes a unique mechanism of action that may slow down or even prevent further kidney damage. This could lead to better outcomes and improved quality of life for patients compared to existing options.

What evidence suggests that BMS-986278 might be an effective treatment for kidney failure?

Research has shown that BMS-986278 may slow the progression of certain diseases. In studies with patients who have progressive pulmonary fibrosis, a 60 mg dose of BMS-986278 taken twice daily reduced the rate of lung function decline by 69% over 26 weeks. This suggests that the drug might slow disease progression by affecting specific pathways that cause tissue damage. Although this data comes from a different condition, it implies that BMS-986278 could also benefit diseases involving tissue damage, such as kidney failure. In this trial, participants will join different groups to evaluate the effectiveness of BMS-986278 for kidney failure. However, research on its effectiveness for kidney failure continues. ^{6 7 8 9 10}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This study is for people with varying degrees of kidney function, from normal to severe impairment or end-stage renal disease requiring intermittent hemodialysis. It's designed to understand how these conditions affect the body's handling of the drug BMS-986278.

Inclusion Criteria

* Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.

1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.

2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of BMS-986278 to evaluate pharmacokinetics and safety

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986278

Trial Overview The trial is testing BMS-986278, focusing on how different levels of kidney health impact the drug's behavior in the body and its safety. The study will proceed in stages based on severity of renal impairment.

How Is the Trial Designed?

Group I: Group B: Period 2 Experimental Treatment 1 Intervention

Group II: Group B: Period 1 Experimental Treatment 1 Intervention

Group III: Group A and C Experimental Treatment 1 Intervention

BMS-986278 is already approved in United States for the following indications:

Approved in United States as BMS-986278 for:

• Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06723535

NCT06723535 | A Study to Evaluate BMS-986278 in ... The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD)

2. news.bms.com news.bms.com/news/details/2023/Bristol-Myers-Squibbs-Investigational-LPA1-Antagonist-Reduces-Rate-of-Lung-Function-Decline-in-Progressive-Pulmonary-Fibrosis-Cohort-of-Phase-2-Study/default.aspx

Bristol Myers Squibb's Investigational LPA1 Antagonist ... Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9263228/

Prescribing SGLT2 Inhibitors in Patients With CKD The primary outcome of this trial was a sustained ≥40% decline in eGFR, ESKD, or death from renal or cardiovascular causes. The EMPA-KIDNEY trial was stopped ...

4. clinicaltrials.eu clinicaltrials.eu/inn/bms-986278/

Bms-986278 – Application in Therapy and Current ... BMS-986278 is an experimental drug currently being studied in clinical trials for the treatment of pulmonary fibrosis, including idiopathic pulmonary fibrosis ...

5. nature.com nature.com/articles/s41591-024-03264-4

Finerenone in heart failure and chronic kidney disease with ... We summarize the efficacy and safety of finerenone on cardiovascular, kidney and mortality outcomes in this pre-specified participant-level pooled analysis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589552/

Safety Summary of the Selective Cytopheretic Device Acute kidney injury (AKI) requiring continuous kidney replacement therapy is a significant complication in ICU patients with mortality rates exceeding 50%.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04523220

NCT04523220 | Study to Investigate the Safety of a Drug ... Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (CONVERT).

8. academic.oup.com academic.oup.com/ckj/article/18/10/sfaf297/8262900

Real-world safety of difelikefalin for chronic kidney disease ... A safety analysis from four Phase 3 clinical studies showed that difelikefalin had an acceptable safety profile; the majority of adverse events ...

9. businesswire.com businesswire.com/news/home/20251108996080/en/Vertex-Presents-Updated-Phase-12-Data-From-RUBY-3-Study-That-Continue-to-Demonstrate-Best-in-Class-Potential-for-Povetacicept-in-Adults-with-IgA-Nephropathy-and-Primary-Membranous-Nephropathy-at-American-Society-of-Nephrology-Kidney-Week

Vertex Presents Updated Phase 1/2 Data From RUBY-3 ... The safety data ... Over-production of these autoantibodies against glomerular antigens results in kidney damage, fibrosis, and renal failure.

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa2304820

Effect of Hemodiafiltration or Hemodialysis on Mortality in ... Several studies have suggested that patients with kidney failure may benefit from high-dose hemodiafiltration as compared with standard hemodialysis.