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NCT03101891 · ClinicalTrials.gov registry record · Phase 1
Renal Anhydramnios Fetal Therapy
A Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Multicystic Dysplastic Kidney, sponsored by Johns Hopkins University.
- Active
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 9
- Study locations
NCT03101891: Active Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Multicystic Dysplastic Kidney, sponsored by Johns Hopkins University.
NCT03101891 is a Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Multicystic Dysplastic Kidney that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 70 participants, above the 28-participant average among 3 other Lower Urinary Tract Obstructive Syndrome trials with a reported enrollment target (150% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101891, a Phase 1 study of Lower Urinary Tract Obstructive Syndrome and Multicystic Dysplastic Kidney, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 9
- Study locations
Study Summary
Early pregnancy renal anhydramnios (EPRA) is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will be carried out by an expert in fetal interventions at a RAFT center. There is a significant risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions, and any potential trial participants will be counseled about these risks before they decide whether to join the trial. Any eligible patients who, after counseling, elect to terminate the pregnancy will not be eligible to participate in the trial. All eligible patients who choose to join the RAFT trial will be able to choose their assignment into one of two arms of the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of patients to study arm will not be random, but will be decided by the participant. Fetuses who do survive after birth will require intensive medical management for kidney failure including placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney transplant. Treatment for lung disease secondary to abnormal lung development may also be required. The study will follow babies and their families until non-survival or tr
Primary Outcome
Neonates who survive to \>= 14 days and placement of dialysis access as well as the exact confidence interval will be presented for CoBRA and fetal renal failure (FRF) patients separately in the FRF and BRA intervention.
Conditions Studied
Interventions
- PROCEDURE Serial amnioinfusions with isotonic fluid
- DEVICE Spinal needle
- DRUG Isotonic fluid
Study Locations (9)
California
- University of Southern California/Children's Hospital of Los Angeles/Huntington Hospital - Los Angeles
- University of California San Francisco - San Francisco
- Stanford University - Stanford
Colorado
- University of Colorado Denver - Aurora
Maryland
- Johns Hopkins Hospital - Baltimore
Minnesota
- Mayo Clinic - Rochester
New York
- Columbia University - New York
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 1 |
What the registry record for NCT03101891 still lists
NCT03101891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 28-participant average among 3 other Lower Urinary Tract Obstructive Syndrome trials with a reported enrollment target (150% higher).
The record links to 7 conditions, with Lower Urinary Tract Obstructive Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Serial amnioinfusions with isotonic fluid is the first listed.
NCT03101891 lists 9 locations in 7 states (California, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT03101891 about?
NCT03101891 is a clinical study titled "Renal Anhydramnios Fetal Therapy". Early pregnancy renal anhydramnios (EPRA) is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Feta...
What is the current status of trial NCT03101891?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2018-12-21. Estimated completion is 2030-02-28.
What conditions does trial NCT03101891 study?
This clinical trial studies the following conditions: Lower Urinary Tract Obstructive Syndrome, Multicystic Dysplastic Kidney, Fetal Renal Anomaly, Anhydramnios, Potter Syndrome.
What interventions are being tested in trial NCT03101891?
The interventions under investigation include: Serial amnioinfusions with isotonic fluid (PROCEDURE), Spinal needle (DEVICE), Isotonic fluid (DRUG).
Who is sponsoring clinical trial NCT03101891?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03101891 being conducted?
This trial has 9 study locations across California, Colorado, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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