NCT02812212

Brief Summary

Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Nov 2017Apr 2027

First Submitted

Initial submission to the registry

June 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 28, 2017

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

8.9 years

First QC Date

June 17, 2016

Last Update Submit

September 27, 2022

Conditions

Ureteropelvic Junction Obstruction

Keywords

ureteropelvic junction obstructioncortical transit time

Outcome Measures

Primary Outcomes (1)

  • risk, during the first year of life, of an increase of 4mm or more in the measure of APRPD by ultrasonography as compared to the baseline measure, according to the presence or not of an abnormal cortical transit ti

    During the first year of life, the antero-posterior renal pelvic diameter will be measured by ultrasonography at baseline, then at 3 months, 6 months and 12 months after baseline. Diuretic renography will be performed only at baseline and the cortical transit time will be classified as normal or abnormal. An increase of 4mm or more of APRPD is the threshold chosen in the study to determine the aggravation of hydronephrosis. The occurence of the increase of 4mm or more in the measure of APRPD will be compared with the normality/abnormality of the cortical transit time in order to determine its value as a prognostic marker.

    3 months, 6 months and 12 months

Study Arms (1)

Open-label

EXPERIMENTAL

Device: ultrasonography and diuretic renography Bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions. Diuretic renography to measure the cortical transit time

Device: ultrasonographyDevice: diuretic renography

Interventions

ultrasonographyDEVICE

bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.

Open-label
diuretic renographyDEVICE

diuretic renography to measure the cortical transit time.

Open-label

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants:
  • Aged of 4 to 8 weeks of life
  • Presenting an ureteropelvic junction obstruction (UPJO) detected before birth by ultrasound
  • Presenting an UPJO, defined by an Antero-Posterior Renal Pelvic Diameter greater or equal to 15 mm, confirmed by ultrasound post-natally between the 1st and 15th day of life
  • Presenting a unilateral UPJO
  • whose legal representatives have provided a signed free and informed written consent for their infant's participation
  • whose at least one of his legal representative is affiliated to national social security

You may not qualify if:

  • Infants presenting:
  • A bilateral UPJO
  • An ureteral dilatation
  • An associated contralateral uropathy
  • A solitary kidney
  • A renal insufficiency
  • Severe associated disabilities ( ie polymalformation syndromes)
  • A concomitant participation in another trial
  • A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
  • A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

CHU de Limoges

Limoges, 87000, France

RECRUITING

CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35023, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de La Réunion

Saint-Denis, 97400, France

RECRUITING

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Luke Harper, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucie Auzanneau

CONTACT

0262359949lucie.auzanneau@chu-reunion.fr

Valérie Fontaine

CONTACT

promotion.drci@chu-reunion.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 24, 2016

Study Start

November 28, 2017

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)