NCT03723564 Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
| NCT ID | NCT03723564 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Renal Failure Congenital |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2018-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Pregnant women with singleton uterine pregnancy * Maternal age \> age 18 * Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure * Fetus \< 26 weeks gestational age with bilateral renal agenesis * Fetus with absence of chromosome abnormalities * Fetus with absence of associated anomalies * Mother has negative Hepatitis B, Hepatitis C, and HIV testing * Mother meets psychosocial criteria that allows her to make a conscious decision about her fetus/infant Exclusion Criteria: * Associated fetal anomaly unrelated to LUTO or renal agenesis * Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth * Placental abnormalities known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal medical condition that is a contraindication to surgery or anesthesia * Mother has declined invasive testing * Inability to comply with the travel and follow-up requirements of the trial * Participation in another interventional study that influences maternal and fetal morbidity and mortality * Participation in this clinical trial during a previous pregnancy
Contact & Investigator
Mauro Schenone, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03723564 clinical trial?
This trial is open to participants of all sexes, studying Renal Failure Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03723564 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03723564 currently recruiting?
Yes, NCT03723564 is actively recruiting participants. Contact the research team at Rasmusson.Taylor@mayo.edu for enrollment information.
Where is the NCT03723564 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03723564 clinical trial?
NCT03723564 is sponsored by Mayo Clinic. The principal investigator is Mauro Schenone, MD at Mayo Clinic. The trial plans to enroll 40 participants.