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Anti-inflammatory

Cohort 1 (Mild Impairment): Brensocatib for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a body mass index (BMI) 18 to 35 kilograms per square meter (kg/m^2), inclusive, and a body weight of ≥50 kg at Screening.
Mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (eGFR) and calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and at multiple timepoints post-dose on days 1 to 14
Awards & highlights

Study Summary

The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.

Eligible Conditions
  • Kidney Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and at multiple timepoints post-dose on days 1 to 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at multiple timepoints post-dose on days 1 to 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Number of Participants who Experienced at Least one Adverse Event (AE)
+1 more

Side effects data

From 2021 Phase 3 trial • 406 Patients • NCT04817332
14%
Infections
4%
Respiratory disorders
3%
Rash
2%
Nausea
2%
Hyperglycaemia
2%
Dyspepsia
2%
Nervous system disorders
2%
Epistaxis
2%
Dizziness
1%
Pruritus
1%
Glossodynia
1%
Oedema peripheral
1%
Peripheral swelling
1%
Extravasation
1%
Hepatic function abnormal
1%
Swollen tongue
1%
Dyspnoea
1%
Supraventricular tachycardia
1%
Vomiting
1%
Constipation
1%
Gastrooesophageal reflux disease
1%
Arthralgia
1%
Serratia infection
1%
Hallucination, visual
1%
Nightmare
1%
Respiratory tract infection
1%
Gastrointestinal disorders
1%
Gastritis erosive
1%
General disorders
1%
Skin disorders
1%
Vascular disorders
1%
Chronic lymphocytic leukaemia
1%
Peripheral ischaemia
1%
Chest discomfort
1%
Swelling face
1%
Hiccups
1%
Pneumothorax
1%
Rhinorrhoea
1%
Pulmonary embolism
1%
Alanine aminotransferase increased
1%
Liver function test abnormal
1%
Glycosylated haemoglobin increased
1%
Blood glucose abnormal
1%
Transaminases increased
1%
Fall
1%
Bradycardia
1%
Palpitations
1%
Tachyarrhythmia
1%
Acute coronary syndrome
1%
Sinus bradycardia
1%
Headache
1%
Memory impairment
1%
Paraesthesia
1%
Vision blurred
1%
Dry mouth
1%
Gingival bleeding
1%
Hypoaesthesia oral
1%
Lip pain
1%
Mouth ulceration
1%
Subcutaneous emphysema
1%
Dry skin
1%
Rash pruritic
1%
Acute kidney injury
1%
Back pain
1%
Muscle spasms
1%
Clostridium difficile colitis
1%
Candida infection
1%
Pneumonia
1%
Urinary tract infection
1%
Staphylococcal bacteraemia
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brensocatib
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4 (Normal): BrensocatibExperimental Treatment1 Intervention
Healthy participants with normal renal function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with renal impairment.
Group II: Cohort 3 (Severe Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group III: Cohort 2 (Moderate Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Group IV: Cohort 1 (Mild Impairment): BrensocatibExperimental Treatment1 Intervention
Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib
2023
Completed Phase 3
~620

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
41 Previous Clinical Trials
7,150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for participants in this clinical trial?

"Clinicaltrials.gov indicates that this research is still recruiting participants, having been posted on the 20th of July 2021 and recently updated on December 21st 2022."

Answered by AI

Is this trial available to individuals aged 80 or older?

"According to the prerequisites for this trial, all participants must be between 18 and 80 years old."

Answered by AI

How many participants are currently being enrolled in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is recruiting patients as of now; the study was initially published on July 20th 2021 and last revised on December 21st 2022. Altogether, 30 participants are being enrolled from two separate centres."

Answered by AI

What criteria is necessary for individuals to qualify for this clinical trial?

"To be considered for the trial, applicants must have declining kidney performance and an age between 18-80. Currently, 30 participants are being recruited to partake in this medical experiment."

Answered by AI

What are the safety profiles of patients in Cohort 1 (Mild Impairment) taking Brensocatib?

"After careful consideration, the safety of Brensocatib for patients with mild impairment was rated an 1 due to limited clinical data surrounding its efficacy and security."

Answered by AI
~8 spots leftby Mar 2025