Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC (KANGUROO)

June 10, 2026 updated by: Urovant Sciences GmbH

A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Withdrawn
        • Universitair Ziekenhuis Antwerpen
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • Recruiting
        • Uz Gent
        • Principal Investigator:
          • Erik Van Laecke
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Bryce Weber
    • Ontario
      • Toronto, Ontario, Canada, M5G 1E8
        • Recruiting
        • The Hospital for Sick Children
        • Principal Investigator:
          • Michael Chua
  • Croatia
      • Split, Croatia, 21000
        • Recruiting
        • University Hospital Split - KBC Split
        • Principal Investigator:
          • Tanja Kovacevic
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine
        • Principal Investigator:
          • Kostas Kamperis
  • Georgia
      • Tbilisi, Georgia, 0159
        • Recruiting
        • JSC Evex Hospital M. lashvili Childrens Central Hospital
        • Principal Investigator:
          • Tinatin Davitaia
  • Jordan
      • Amman, Jordan, 11942
        • Recruiting
        • Jordan University Hospital
        • Principal Investigator:
          • Raed Altaher
      • Amman, Jordan, 11821
        • Recruiting
        • Istiklal Hospital
        • Principal Investigator:
          • Mohammad Al-Zubi
      • Irbid, Jordan, 21110
        • Recruiting
        • Irbid Specialty Hospital
        • Principal Investigator:
          • Osama Bani-Hani
  • Latvia
      • Riga, Latvia, LV-1004
        • Withdrawn
        • Childrens Clinical University Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Principal Investigator:
          • Sarunas Rudaitis
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos
        • Principal Investigator:
          • Beata Vincel
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Kuala Lumpur Hospital
        • Principal Investigator:
          • Poongkodi Nagappan
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Hospital Umum Sarawak
        • Principal Investigator:
          • Ing Soon Ngu
  • Philippines
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1102
        • Recruiting
        • National Children's Hospital
        • Principal Investigator:
          • Carlo Bisnar
  • Poland
      • Bialystok, Poland, 15-274
        • Recruiting
        • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
        • Principal Investigator:
          • Anna Wasilewska
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Principal Investigator:
          • Michal Maternik
      • Warsaw, Poland, 04-736
        • Recruiting
        • Instytut Pomnik - Centrum Zdrowia Dziecka
        • Principal Investigator:
          • Piotr Gastol
  • Romania
    • Bucharest
      • Bucharest, Bucharest, Romania, 22328
        • Recruiting
        • Institutul Clinic Fundeni
        • Principal Investigator:
          • Robert Stoica
      • Bucharest, Bucharest, Romania, 41451
        • Recruiting
        • Maria Sklodowska Curie Childrens Clinical Emergency Hospital
        • Principal Investigator:
          • Beatrice Bunea
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Children's Hospital Tirsova
        • Principal Investigator:
          • Dusan Parapovic
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Children and Youth Health Care Institute of Vojvodina
        • Principal Investigator:
          • Dragan Sarac
  • Slovakia
      • Bratislava, Slovakia, 83301
        • Recruiting
        • Detská fakultná nemocnica s poliklinikou/Národný ústav detských chorôb (NÚDCH)
        • Principal Investigator:
          • Peter Barton
      • Bratislava, Slovakia, 85101
        • Recruiting
        • Urologická ambulancia J. BREZA MEDICAL s.r.o.
        • Principal Investigator:
          • Jan Breza
  • Turkey (Türkiye)
      • Yenişehir, Turkey (Türkiye), 33343
        • Recruiting
        • Mersin University, Dept. of Urology
        • Principal Investigator:
          • ERİM ERDEM
    • Altindag
      • Ankara, Altindag, Turkey (Türkiye), 6230
        • Recruiting
        • Ankara University Faculty of Medicine Ibni Sina Hospital
        • Principal Investigator:
          • Berk Burgu
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Childrens Hospital
        • Principal Investigator:
          • Ashay Patel
    • California
      • Orange, California, United States, 92868-4568
        • Terminated
        • Children's Hospital of Orange County
    • Colorado
      • Aurora, Colorado, United States, 800045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Kyle Rove
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Childrens Health, Jacksonville
        • Principal Investigator:
          • Andrew Stec
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
        • Principal Investigator:
          • Kahlil N Saad
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Withdrawn
        • Childrens Hospital New Orleans
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Principal Investigator:
          • Alexandra Rehfuss
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Principal Investigator:
          • Jeffery Villanueva
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Terminated
        • Duke University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Principal Investigator:
          • Dominic Frimberger
    • Oregon
      • Portland, Oregon, United States, 97239
        • Withdrawn
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants, age 2 years to < 18 years and weighing at least 11 kg at the Screening Visit.
  • Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord injury or spinal cord surgery, with the injury/surgery having occurred at least 6 months prior to the Screening Visit; or acquired NDO due to transverse myelitis with diagnosis at least 12 months prior to the Screening Visit.
  • 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.

Exclusion Criteria:

  • Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
  • Participant has an active malignancy in the 12 months prior to the Screening Visit.
  • Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study.
  • Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study.
  • Participant currently uses or plans to use a baclofen pump during the study.
  • Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.
  • Participant has undergone bladder augmentation surgery.
  • Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms.
  • Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has undergone pelvic gender reassignment surgery.
  • Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form.
  • Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment.
  • Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit.
  • Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure.
  • Participant started electrostimulation/neuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period.
  • Participant has participated in another clinical trial and/or has taken an investigational drug within 4 weeks prior to the Screening Visit.
  • Participant is unable, or parent/caregiver is not willing, to washout any medication for the management of NDO.
  • Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study.
  • Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Weight >=41.5kg

Part A: Participants will receive a dose of 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.
Drug: Vibegron
Participants will be administered Vibegron orally, once daily (QD)
Experimental: Cohort 2: Weight Range >=29.5 kg to <=41.4 kg

Part A: participants will receive a dose of 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 DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
Drug: Vibegron
Participants will be administered Vibegron orally, once daily (QD)
Experimental: Cohort 3: Weight range >=11 kg to <=29.4 kg

Part A: Participants will receive a dose of 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 DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
Drug: Vibegron
Participants will be administered Vibegron orally, once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics
Time Frame: Optimized Treatment Week 24
Optimized Treatment Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in MCC
Time Frame: Optimized Week 12
Optimized Week 12
Change from Baseline in number of overactive detrusor contractions until the end of bladder filling
Time Frame: Optimized Treatment Weeks 12 and 24
Optimized Treatment Weeks 12 and 24
Change from Baseline in detrusor pressure at the end of bladder filling
Time Frame: Optimized Treatment Weeks 12 and 24
Optimized Treatment Weeks 12 and 24
Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction
Time Frame: Optimized Treatment Weeks 12 and 24
Optimized Treatment Weeks 12 and 24
Change from Baseline in bladder compliance (mL/cm H2O)
Time Frame: Optimized Treatment Weeks 12 and 24
Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder
Optimized Treatment Weeks 12 and 24
Change from Baseline in average first morning catheterized volume
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in average catheterized volume per catheterization
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in average maximum catheterized volume per day
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in average maximum catheterized daytime volume
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in average number of leakage episodes per day
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in estimated number of dry (leakage-free) days/ 7 days
Time Frame: through study completion, an average of 52 weeks
through study completion, an average of 52 weeks
Change from Baseline in Pediatric Incontinence Questionnaire (PIN-Q)
Time Frame: through study completion, an average of 52 weeks
PIN-Q is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicating more impact on the quality of life.
through study completion, an average of 52 weeks
Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale
Time Frame: through study completion, an average of 52 weeks
PGI-S is a 5 point scale that determines the bladder condition of a participant with 0 being really bad and 4 as really good. Higher score indicates better bladder condition.
through study completion, an average of 52 weeks
Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale
Time Frame: through study completion, an average of 52 weeks
The CGI-C scale is used to determine the degree of change in participant's overall bladder symptoms since the start of the study on Day 1. The scale will be filled by the investigator by ticking on any of the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.
through study completion, an average of 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urovant Sciences GmbH

Collaborators

Sumitomo Pharma America, Inc.

Investigators

  • Study Director: Janet Owens-Grillo, Sumitomo Pharma America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-901-3007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.

IPD Sharing Time Frame

The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.

IPD Sharing Access Criteria

Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe