Trial Outcomes & Findings for Renal Anhydramnios Fetal Therapy (NCT NCT03101891)

Last Updated: 2026-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

55 participants

Primary outcome timeframe

Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks

Results posted on

2026-07-01

Participant Flow

There are two arms (FRF, BRA) in the trial. 55 pregnant women (mother and unborn fetus) were enrolled; Fetal renal failure (FRF) arm-32 enrolled in the intervention; Bilateral renal agenesis (BRA) arm-18 enrolled in the intervention; Expectant Management (EM) - 5 participants chose Expectant Management over the intervention arms. Infants were not enrolled in the trial, live infant births and infant survival were study outcome measures.

Participant milestones

Participant milestones
Measure	Fetal Renal Failure Serial Amnioinfusion (FRF) Arm FRF maternal-fetal pairs receiving treatment through serial amnioinfusions. 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.	Bilateral Renal Agenesis Serial Amnioinfusion (BRA) Arm BRA maternal-fetal pairs receiving treatment through serial amnioinfusions. 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.	Expectant Management (EM) Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
Overall Study STARTED	32	18	5
Overall Study Maternal-fetal Pairs Starting and Completing the Study	32	18	5
Overall Study Fetuses Who Progressed to Live Birth and Completed the Study	29	17	5
Overall Study Fetal Demise in Utero	3	1	0
Overall Study Bilateral Renal Agenesis	0	0	3
Overall Study Fetal Renal Failure	0	0	2
Overall Study COMPLETED	32	18	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Anhydramnios Fetal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=32 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=18 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	EM (Expectant Management) n=5 Participants FRF and BRA patients who often for EM instead of the intervention.	Total n=55 Participants Total of all reporting groups
Age, Continuous	29.3 Years STANDARD_DEVIATION 4.0 • n=9 Participants	32.1 Years STANDARD_DEVIATION 6.4 • n=27 Participants	31.8 Years STANDARD_DEVIATION 3.5 • n=267 Participants	30.4 Years STANDARD_DEVIATION 5.0 • n=265 Participants
Sex: Female, Male Mothers · Female	32 Participants n=9 Participants	18 Participants n=27 Participants	5 Participants n=267 Participants	55 Participants n=265 Participants
Sex: Female, Male Mothers · Male	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Ethnicity (NIH/OMB) Maternal Ethnicity · Hispanic or Latino	12 Participants n=9 Participants	2 Participants n=27 Participants	1 Participants n=267 Participants	15 Participants n=265 Participants
Ethnicity (NIH/OMB) Maternal Ethnicity · Not Hispanic or Latino	20 Participants n=9 Participants	16 Participants n=27 Participants	4 Participants n=267 Participants	40 Participants n=265 Participants
Ethnicity (NIH/OMB) Maternal Ethnicity · Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=267 Participants	1 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · Asian	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · Native Hawaiian or Other Pacific Islander	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · Black or African American	4 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	4 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · White	22 Participants n=9 Participants	17 Participants n=27 Participants	4 Participants n=267 Participants	43 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · More than one race	2 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	2 Participants n=265 Participants
Race (NIH/OMB) Maternal Race · Unknown or Not Reported	2 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	3 Participants n=265 Participants

PRIMARY outcome

Timeframe: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks

Population: This outcome was only assessed for infants who were born alive the FRF and BRA Intervention groups.

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=29 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=17 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Neonates Surviving to >= 14 Days and Placement of Dialysis Access After Serial Amnioinfusions	19 Participants	14 Participants

SECONDARY outcome

Timeframe: During the EPRA pregnancy

Population: Participants enrolled in the FRF and BRA interventions arm who elected to undergo serial amnioinfusions.

The feasibility of serial amnioinfusions for EPRA will be assessed using the incidence of PPROM in the FRF and BRA intervention arms.

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=32 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=18 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Participants Who Experienced PPROM While Receiving Serial Amnioinfusions	19 Participants	12 Participants

SECONDARY outcome

Timeframe: During the EPRA pregnancy

Population: Participants enrolled in the FRF and BRA intervention arms who elected to undergo serial amnioinfusions.

The feasibility of serial amnioinfusions for EPRA will be measured using the time from the first amnioinfusion to PPROM in the FRF and BRA arms.

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=32 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=18 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Median Time From First Amnioinfusion to PPROM in Those Receiving Serial Amnioinfusions	61 Days Interval 32.0 to 69.0	52.5 Days Interval 33.0 to 70.5

SECONDARY outcome

Timeframe: During the EPRA pregnancy

Population: Participants enrolled in the FRF and BRA intervention arms who elected to undergo serial amnioinfusions.

Investigators will assess the feasibility of the intervention by gestational age at delivery in the FRF and BRA arms.

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=32 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=18 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Median Gestational Age at Delivery Among Those in the Intervention Arm	34 Weeks Interval 31.0 to 35.0	33 Weeks Interval 32.0 to 34.0

SECONDARY outcome

Timeframe: From birth until the date of hospital discharge, approximately 5 months

Population: Live births in the FRF and BRA intervention arms

Assess the long-term efficacy of the intervention by infant survival to discharge

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=29 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=17 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Infants Surviving to Hospital Discharge in the FRF and BRA Intervention Arms	14 Participants	6 Participants

SECONDARY outcome

Timeframe: Duration of Pregnancy

Natural history of ERPA pregnancy in non-intervention patients

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=5 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Rate of in Utero Fetal Demise in Those in the Non-intervention Arm	0 Participants	—

SECONDARY outcome

Timeframe: Length of pregnancy

Population: Includes only Intervention Arm pregnancies

Assess the feasibility of the intervention in terms of fetal survival

Outcome measures

Outcome measures
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) n=32 Participants FRF maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) n=18 Participants BRA maternal-fetal pairs receiving treatment through serial amnioinfusions in the intervention arm.
Rate of in Utero Fetal Demise in the Intervention Arm	3 Participants	1 Participants

Adverse Events

FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) Pregnant Women

Serious events: 7 serious events

Other events: 28 other events

Deaths: 0 deaths

BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) Pregnant Women

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

EM (Expectant Management) Pregnant Women

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FRF Intervention (Fetal Renal Failure Serial Amnioinfusion Arm) Pregnant Women n=32 participants at risk Women with FRF receiving serial amnioinfusions. Observed time from study enrollment until delivery.	BRA Intervention (Bilateral Renal Agenesis Serial Amnioinfusion Arm) Pregnant Women n=18 participants at risk Women with fetal BRA receiving serial amnioinfusions. Observed time from study enrollment until delivery.	EM (Expectant Management) Pregnant Women n=5 participants at risk Patients will be observed serially by ultrasound, fetal echocardiogram and MRI. Standard postnatal care will occur at a RAFT center.
Pregnancy, puerperium and perinatal conditions Preterm Premature Rupture of Membranes (PPROM)	0.00% 0/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	5.6% 1/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.
Pregnancy, puerperium and perinatal conditions Premature delivery	3.1% 1/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.
Pregnancy, puerperium and perinatal conditions Bleeding in absence of placental abruption	0.00% 0/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	11.1% 2/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal condition	6.2% 2/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.
Pregnancy, puerperium and perinatal conditions Fetal Loss	9.4% 3/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	5.6% 1/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.
Cardiac disorders Cardiac Disorders	6.2% 2/32 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/18 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.	0.00% 0/5 • From enrollment up to 40 weeks Reported by healthcare provider. Adverse events (AEs) were only collected for pregnant participants who underwent study intervention. AEs not collected for surviving infants. Fetal death classified as maternal serious adverse event (not AE for live infant). Infant survival was an outcome measure, but non-survival is not an AE; it is one of the possible expected outcomes for infant born needing dialysis. Study design did not include collection and classification of AEs for surviving infants.

Other adverse events

Additional Information

Meredith A. Atkinson, MD, MHS

Johns Hopkins University School of Medicine, Division of Pediatric Nephrology

Phone: 410-955-2467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place