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Beta-3 Adrenergic Agonist
Vibegron for Pediatric Bladder Disorder (KANGUROO Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Urovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants age 12 to < 18 years (Cohort 1) must weigh at least 29.5 kilograms (kg)
Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at weeks 1, 4, 8, 20, 32, 48, and 52
Awards & highlights
KANGUROO Trial Summary
This trial will test a new drug to help kids with a bladder condition called NDO, to see if it's safe and effective.
Who is the study for?
This trial is for children aged 2 to <18 with Neurogenic Detrusor Overactivity (NDO) due to spinal conditions or injury, who use Clean Intermittent Catheterization (CIC). They must weigh at least 11 kg if under 12 years old, and at least 29.5 kg if between 12 and <18 years old. Those with recent urethral procedures, bladder surgeries, active cancers, certain medication usage or unwillingness to stop NDO medications are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug called Vibegron in young patients with overactive bladders due to NDO. It will also assess how the body processes the drug. Participants are divided into two groups based on age: one for ages 2-<12 and another for ages 12-<18.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like Vibegron may include dry mouth, constipation, blurred vision, dizziness and urinary tract infections. The exact side effects experienced by participants will be monitored throughout the trial.
KANGUROO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am aged 12-17 and weigh at least 29.5 kg.
Select...
I have been performing self-catheterization at least 3 times daily for over 4 weeks.
KANGUROO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at weeks 1, 4, 8, 20, 32, 48, and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at weeks 1, 4, 8, 20, 32, 48, and 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Bladder
Secondary outcome measures
Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale
Change from Baseline in MCC
Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale
+11 moreSide effects data
From 2019 Phase 3 trial • 506 Patients • NCT035833729%
Hypertension
7%
Urinary tract infection
5%
Dry mouth
5%
Nasopharyngitis
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Tolterodine ER 4 mg
Overall Vibegron 75 mg
KANGUROO Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Vibegron Children (2 to < 12 years)Experimental Treatment1 Intervention
Part A: Participants aged 2 to < 12 years will receive vibegron based on their weight, after DSMB review of Cohort 1, Part A data, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times.
Part B: Participants will receive a DSMB-selected vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
Group II: Cohort 1: Vibegron Adolescents (12 to < 18 years)Experimental Treatment1 Intervention
Part A: Participants aged 12 to < 18 years will receive vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times.
Part B: Participants will receive a Data and Safety Monitoring Board (DSMB)-selected vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibegron
2018
Completed Phase 3
~3520
Find a Location
Who is running the clinical trial?
Urovant Sciences GmbHLead Sponsor
10 Previous Clinical Trials
4,179 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am aged 2 to under 12 years and weigh at least 11 kg.I am not breastfeeding nor plan to during the study and until 28 days after the last drug dose.I have cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or high blood pressure.I have a serious digestive issue, like blockage or poor movement in my intestines.I am aged 12-17 and weigh at least 29.5 kg.I have had surgery to make my bladder larger.I have a bladder condition causing overactivity or incontinence, not including NDO.I have had severe constipation needing hospital or surgical treatment in the last 3 months.I or my caregiver cannot stop my current NDO medication.I have severe kidney issues or a serious urinary tract condition.I have had surgery or treatment for bladder control issues or gender reassignment surgery in the last 6 months.I have received bladder botox in the last 9 months and will not use it during the study.I am between 2 and 17 years old.You are currently using or planning to use a baclofen pump during the study.You have used a urinary catheter in the 4 weeks before the screening visit.I have been performing self-catheterization at least 3 times daily for over 4 weeks.I have had urethral surgery or dilatation in the last 3 months.I have had cancer activity within the last 12 months.I have taken digoxin or lithium recently or plan to start during the study.I am a woman who can have children and will not use birth control during the study.I have NDO due to a spinal condition or injury that happened at least 6 months ago.I started or will start electrostimulation therapy around the time of joining this study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Vibegron Adolescents (12 to < 18 years)
- Group 2: Cohort 2: Vibegron Children (2 to < 12 years)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there specific criteria for eligibility in this clinical experiment?
"In this clinical trial, 85 individuals aged 2-17 suffering from neurogenic detrusor overactivity are being recruited. All participants must fit the following criteria - male or female, at least 11kg in weight (Cohort 2), 29.5 kg for Cohort 1 (12 to < 18 years old) and perform CIC 3 times a day for 4 weeks prior to enrollment. Additionally, NDO can be caused by spinal dysraphism such as spina bifida or other injury/surgery occurring 6 months before screening visit; transverse myelitis diagnosis 12 months before Screening Visit is also accepted."
Answered by AI
How many participants have signed up to participate in this experiment?
"Affirmative. The details published on clinicaltrials.gov corroborate that this medical trial, with an inception date of October 12th 2022, is actively seeking participants. 85 individuals must be recruited between 6 different sites."
Answered by AI
Are there currently any vacancies for this experiment?
"This trial is actively accepting participants, its posting dating back to October 12th 2022 with the latest update occurring on June 12th 2023. Such information can be found on clinicaltrials.gov."
Answered by AI
How many venues are offering this research project?
"This trial is operating at 6 distinct sites, 3 of which are located in Jacksonville, Wichita and New Orleans. When enrolling it's important to consider proximity as travel may be necessary depending on the location chosen."
Answered by AI
Are elderly persons over the age of 85 able to participate in this research?
"To be included in this trial, participants should range from 2 years old to 17. Moreover, there are nine different trials for minors and an additional 65 that cater towards elderly individuals."
Answered by AI
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