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NCT03723564 · ClinicalTrials.gov registry record · Phase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
A Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Renal Failure Congenital, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03723564: Recruiting Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Renal Failure Congenital, sponsored by Mayo Clinic.
NCT03723564 is a Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Renal Failure Congenital that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 40 participants, roughly in line with the 38-participant average among 3 other Lower Urinary Tract Obstructive Syndrome trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03723564, a Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Renal Failure Congenital, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%) requiring dialysis or renal transplantation if no fetal intervention is performed. Renal agenesis is the congenital absence of one or both kidneys due to complete failure of the kidney to form. As many as 33% of fetuses with bilateral renal agenesis are stillborn, and the rest of them die immediately after birth due to severe pulmonary hypoplasia. The objective of the serial amnioinfusions for fetuses with these conditions will be to reduce the severity of pulmonary hypoplasia (regenerating the lung functionality) and therefore increase the chance that the newborn survives to begin peritoneal dialysis. Although there is initial evidence that serial amnioinfusions are feasible for the pregnant women and the fetuses, there is still a need to have a prospective clinical trial to confirm the hypothesis that serial amnioinfusions could prevent severe pulmonary hypoplasia allowing the newborns with bilateral renal agenesis or severe LUTO to survive to begin peritoneal dialysis. Therefore, the investigators aim to study the hypothesis that serial amnioinfusions for fetuses with severe LUTO and renal failure and those with bilateral renal agenesis will reduce the severity of pulmonary hypoplasia and therefore increase the chance that the newborn survives to begin peritoneal dialysis.
Primary Outcome
Total number of Adverse Events experienced
Conditions Studied
Interventions
- DRUG Lactated Ringers Solution for Injection
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT03723564 shows while recruiting
NCT03723564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, roughly in line with the 38-participant average among 3 other Lower Urinary Tract Obstructive Syndrome trials with a reported enrollment target.
The record links to 4 conditions, with Lower Urinary Tract Obstructive Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Lactated Ringers Solution for Injection is the first listed.
NCT03723564 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03723564 about?
NCT03723564 is a clinical study titled "Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia". Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic ...
What is the current status of trial NCT03723564?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-10-01. Estimated completion is 2027-12-31.
What conditions does trial NCT03723564 study?
This clinical trial studies the following conditions: Lower Urinary Tract Obstructive Syndrome, Renal Failure Congenital, Congenital Renal Anomaly Nos, Renal Agenesis and Dysgenesis.
What interventions are being tested in trial NCT03723564?
The interventions under investigation include: Lactated Ringers Solution for Injection (DRUG).
Who is sponsoring clinical trial NCT03723564?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03723564 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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