What side effects are associated with this type of intervention?

Serial amnioinfusions, used to promote lung development in fetuses with conditions like Multicystic Dysplastic Kidney, carry significant risks including early rupture of membranes and preterm delivery. Other common treatments for MCDK, such as monitoring and supportive care, generally have fewer direct side effects but may involve complications related to the underlying kidney condition, such as hypertension or urinary tract infections. Postnatal management may require interventions like dialysis or kidney transplantation, which come with their own risks, including infection, rejection, and complications from long-term immunosuppression.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Multicystic Dysplastic Kidney (MCDK) mentioned in the provided context. However, the RAFT trial explores the use of serial amnioinfusions to promote lung development in fetuses with renal anhydramnios, a condition related to severe kidney issues. This experimental therapy involves the physical addition of fluid to the amniotic space to support lung growth, which may be relevant for conditions like MCDK that impact fetal development.

What other types of research exist?

As of the current knowledge, there are no specific novel alternatives to serial amnioinfusions for promoting lung development in Multicystic Dysplastic Kidney (MCDK) patients. The primary approach remains careful monitoring and follow-up with ultrasound scans to assess kidney involution and function. Surgical interventions may be considered if complications arise. Patients should consult with their healthcare provider for the most up-to-date treatment options.

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Serial Amnioinfusions for Low Amniotic Fluid (RAFT Trial)

Phase 1

Recruiting

Led By Eric B Jelin, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed anhydramnios before 22 weeks GA for patients with fetal renal failure (excluding bilateral renal agenesis)

Confirmation that the expectant mother does not wish to undergo termination of the pregnancy

Must not have

Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment

No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of follow-up, up to 4 years after transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a method of injecting fluid into the womb of pregnant women whose fetuses have a severe kidney condition that prevents normal lung development. The goal is to help the fetus's lungs grow so they can survive after birth. The trial focuses on the safety and effectiveness of this treatment for fetuses with urinary tract issues.

Who is the study for?

This trial is for pregnant women over 18 with a fetus diagnosed with EPRA, excluding bilateral renal agenesis. They must be before 22 weeks gestation, not planning to terminate the pregnancy, and able to start treatment before 26 weeks. Participants need to deliver at a RAFT center and agree to postnatal care there.

What is being tested?

The RAFT Trial tests serial amnioinfusions of isotonic fluid into the womb against standard monitoring without infusions. The goal is for the infused fluid to help fetal lung growth in cases where kidney issues have led to low amniotic fluid levels.

What are the potential side effects?

Potential side effects include early rupture of membranes and premature delivery. Babies who survive may require intensive medical management for kidney failure (dialysis, transplant) and treatment for lung disease due to abnormal development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby has been diagnosed with renal failure, not due to missing kidneys, with no amniotic fluid before 22 weeks.

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I do not plan to terminate my pregnancy.

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I am an expectant mother and I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have depression that hasn't improved with treatment, confirmed by a test score.

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My genetic tests show no significant abnormal findings.

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My cervix is shorter than 2.5 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of follow-up, up to 4 years after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of follow-up, up to 4 years after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of follow-up, up to 4 years after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of neonates surviving to >= 14 days and placement of dialysis access after serial amnioinfusions (defined as use of a dialysis catheter for >=14 continuous days)

Secondary study objectives

Correlations between fetal ultrasound, echocardiogram MRI biomarkers as well as amniotic fluid biomarkers, and the success of RAFT for EPRA

Mean gestational age at delivery among those in the intervention arm

Mean gestational age at delivery among those in the non-intervention arm

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Serial amnioinfusions with isotonic fluidExperimental Treatment3 Interventions

There are two interventional arms to the trial. Recruitment in the bilateral renal agenesis arm of the trial was stopped in July 2022 after DSMB review. Recruitment is ongoing in the non-bilateral renal agenesis, fetal renal failure with anhydramnios arm of the trial. Patients will undergo amnioinfusions with isotonic fluid every 2-12 days.. A spinal needle will be used to perform the infusion. The latest infusions will begin is 26 weeks gestation. Standard postnatal care will occur at a RAFT center.

Group II: ExpectantActive Control1 Intervention

Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal needle

2022

N/A

~160

Isotonic fluid

2006

Completed Phase 3

~170

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Multicystic Dysplastic Kidney (MCDK) involving the physical addition of fluid to the amniotic space, such as serial amnioinfusions, works by maintaining adequate amniotic fluid levels. This is crucial for promoting fetal lung development and preventing pulmonary hypoplasia, a severe complication due to oligohydramnios. By ensuring proper lung development, this treatment significantly improves the chances of survival and better health outcomes for MCDK patients post-birth.

Experimental congenital obstructive uropathy.Differential Diagnosis and Prognosis of Fetuses with Bilateral Enlarged, Hyperechogenic Kidneys: Renal Volume and Amniotic Fluid Volume with Advancing Gestation.Development of fetal and neonatal renal function.