BPN14770 for Kidney Failure

Recruiting at 2 trial locations

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shionogi

Disqualifiers: Cardiovascular, Respiratory, Renal, Liver, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new treatment, BPN14770, functions in individuals with severe kidney problems and those with normal kidney function. The main goals are to assess safety and understand how the body processes this medication. Participants will be divided into two groups: one with severe kidney issues and the other with normal kidney function. This trial suits individuals with severe kidney problems who are not on dialysis, as well as healthy individuals with normal kidney function. 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 medication.

Will I have to stop taking my current medications?

The trial requires that participants with renal impairment maintain a stable medication regimen, meaning you should not start new medications or change dosages within 14 days before starting the study and throughout the study period.

Is there any evidence suggesting that BPN14770 is likely to be safe for humans?

Research has shown that BPN14770 has been tested in other human studies. In these studies, 147 people took BPN14770, and the results indicated it was very safe. Participants took the drug orally, and it was well-tolerated, with most experiencing no serious side effects.

BPN14770 is also being studied for other conditions, such as Fragile X Syndrome, where it has demonstrated positive safety results. This suggests the drug is generally safe, even though this trial focuses on individuals with kidney issues.

While the current study is in an early phase, past studies suggest BPN14770 could be safe to try in this new group of participants. However, as with any clinical trial, unknown risks may still exist. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney failure?

Unlike the standard treatments for kidney failure, which often include dialysis and kidney transplants, BPN14770 is unique because it targets specific mechanisms at the cellular level. This drug is thought to influence cognitive pathways, which might play a role in the body's response to kidney impairment. Researchers are excited about BPN14770 because it offers a novel approach by potentially improving kidney function through a new mechanism of action, which could lead to better outcomes and fewer side effects compared to existing options.

What evidence suggests that BPN14770 might be an effective treatment for kidney failure?

Studies have shown that BPN14770, a medication that blocks an enzyme linked to inflammation, has produced promising results in other conditions. In trials conducted in 2020, patients who took BPN14770 experienced positive outcomes. This suggests that BPN14770 might help manage kidney-related issues by improving symptoms or slowing disease progression. However, while the drug appears promising, its effectiveness specifically for kidney failure remains under investigation. In this trial, participants with either normal renal function or severe renal impairment will receive a single dose of BPN14770. The current research aims to understand how the drug works in the body and its safety for people with kidney problems. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with severe renal impairment (eGFR <30 mL/min) and healthy controls matched by sex, age (±10 years), and BMI (±10%). Participants must be stable on current medications, have a body weight ≥50 kg, BMI between 18.5 to <40.0 kg/m^2, and no significant medical conditions or recent COVID-19 contact.

Inclusion Criteria

I match a participant with severe kidney issues in sex, age, and body weight.

I have severe kidney problems but am not on dialysis.

My medications have been the same for the last 14 days.

Exclusion Criteria

All Participants must not have a current or chronic history of liver disease or biliary abnormalities, history of GI surgery resulting in clinically significant abnormality in GI function, lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, fluctuating or rapidly deteriorating renal function, any condition requiring medication and/or other treatment other than protocol-specified medication for participants with renal impairment, poor venous access, history of COVID-19 infection within 14 days prior to the screening visit or admission to the CRU, close contact with a COVID-19 patient in the 14 days prior to the screening visit or admission to the CRU, sensitivity to the study intervention, or components thereof, or a drug or other allergy, including food allergy, that contraindicates participation in the study

I don't have major health issues that could affect the study drug's safety or results.

I do not have acute renal failure, a kidney transplant, or need dialysis.

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 BPN14770 administered orally in the fasted state on Day 1

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BPN14770

Trial Overview The study tests BPN14770's effects in those with severe kidney problems compared to healthy individuals. It looks at how the drug moves through the body, its safety, and if it's easy to tolerate when taken by people with different levels of kidney function.

How Is the Trial Designed?

Group I: Group 2: Participants With Normal Renal Function Experimental Treatment 1 Intervention

Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.

Group II: Group 1: Participants With Severe Renal Impairment Experimental Treatment 1 Intervention

Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07012005?term=AREA%5BBasicSearch%5D(BPN14770)&rank=3

Study of BPN14770 in Participants With Severe Renal ... Study Overview. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0038927

Impaired Renal Function (DBCOND0038927) A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney ...

3. reporter.nih.gov reporter.nih.gov/project-details/10937430

WANG, MING Foundational treatment strategies for slowing CKD progression involve blood pressure-lowering agents, including renin-angiotensin system inhibitors and calcium ...

4. mdpi.com mdpi.com/1420-3049/27/15/4964

An Overview of PDE4 Inhibitors in Clinical Trials: 2010 to ... BPN14770 completed phase II clinical trials in 2020 and the results are encouraging, since the treatment of the patients with an oral dose 25 mg twice daily ...

5. ctv.veeva.com ctv.veeva.com/study/pharmacokinetics-and-safety-of-rupatadine-in-participants-with-renal-impairment-compared-to-control

Pharmacokinetics and Safety of Rupatadine in Participants ... The purpose of this study is to assess the PK, tolerability, and safety of rupatadine (10 mg) and its active metabolites in participants ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07012005

NCT07012005 | Study of BPN14770 in Participants With ... The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those ...

7. hcplive.com hcplive.com/view/bpn14770-orphan-drug-designation

Fragile X Syndrome Therapy Granted Orphan Drug ... BPN14770 has completed a trio of human Phase 1 clinical trials, enrolling 147 subjects in total, and showing exceptional safety, oral ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6135860/

Memory enhancing effects of BPN14770, an allosteric inhibitor ... BPN14770 was 100-fold more potent for improving memory than in wild-type mice; meanwhile, it exhibited low potency in a mouse surrogate model for emesis.