Multicystic Dysplastic KidneyNCT06728228
Amnioinfusion for Fetal Renal Failure
A study testing Amnioinfusion in people with Multicystic Dysplastic Kidney and Polycystic Kidney Disease, run by Fetal Care Center, PLLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multicystic Dysplastic Kidney, Polycystic Kidney Disease, Fetal Renal Anomaly
- What is being tested?
- Amnioinfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed anhydramnios before 22 weeks GA for patients with FRF.
- Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
- Confirmation that the expectant mother understands her options for management of the pregnancy.
- Age ≥18 years of age.
- Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
- Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
- Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.
Who cannot join
- Cervix less than 2.5 cm in length.
- No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).
- Other significant congenital anomalies in the fetus.
- Evidence of chorioamnionitis or abruptio placentae.
- Evidence of rupture of membranes or chorionic-amniotic separation.
- Evidence of preterm labor.
Show all 10Show fewer
- Multiple gestation.
- Severe maternal medical condition in pregnancy.
- Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
- Technical limitations precluding amnioinfusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fetal Care Center
Dallas, Texas, 75230
Kevin P Magee, M.D., (972) 566-5600, kevin.magee@fetalcaredallas.com
About this study
The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are:
- Can serial amnioinfusion increase the chances of survival for these fetuses?
- Does this procedure improve chances of survival until dialysis and/or kidney transplant?
Read more
Participants will:
- Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity.
- Undergo monitoring to check the effects on the fetus and mother.
This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.
Read the detailed description
Fetal renal failure (FRF) is a severe and life-threatening condition caused by congenital abnormalities or inherited kidney diseases. In the womb, when the kidneys fail to function properly, this leads to a condition called anhydramnios-a complete lack of amniotic fluid. Amniotic fluid is essential for the fetus's lung development, particularly during the canalicular phase of pulmonary development, which occurs between 16 and 28 weeks of gestation. Without sufficient amniotic fluid, the lungs cannot develop properly, resulting in a condition known as pulmonary hypoplasia. Severe hypoplasia has previously been described as almost always fatal, typically leading to neonatal death shortly after birth.
In recent years, promising advances in fetal therapies have opened new doors for treating conditions that were once considered untreatable. One such intervention involves serial amnioinfusion, a procedure where sterile saline or another isotonic fluid is injected into the amniotic sac to restore fluid levels. Early studies, including the RAFT trial (Renal Anhydramnios Fetal Therapy), have demonstrated that this approach may improve survival rates by promoting lung development in fetuses with FRF. Building upon these findings, this study seeks to further evaluate the safety and effectiveness of serial amnioinfusion in improving neonatal outcomes for families facing this diagnosis.
This study will enroll approximately 60 pregnant individuals carrying singleton pregnancies complicated by FRF and anhydramnios. Participants will be divided into two groups: an intervention group, which will receive serial amnioinfusion procedures as deemed appropriate by the study doctor, and a control group, which will not undergo interventions and will receive comfort care for their pregnancies. The primary goals of the study are to evaluate maternal safety, assess fetal survival to dialysis, and determine survival to kidney transplant eligibility.
The amnioinfusion procedures will be performed at the Fetal Care Center by a team of experts in fetal procedures. To ensure patient safety, the study includes a rigorous monitoring plan to track any potential adverse events in real time. Data from imaging studies (e.g., ultrasound, echocardiogram, MRI) and laboratory biomarkers will be collected to evaluate fetal and maternal responses to the treatment. While the study focuses on improving outcomes for individual patients, it also has broader implications for science and society. By systematically analyzing the benefits and risks of serial amnioinfusion, this research could help refine treatment protocols and set the stage for new standards of care for FRF. For the families involved, participation in this study offers the possibility of improved survival for their children, with potential eligibility for life-saving kidney transplants in the future.
This study represents a critical step toward addressing a condition that has long been considered untreatable. Through collaboration, innovation, and rigorous research, the team aims to provide hope for families affected by FRF.
- Conditions
- Multicystic Dysplastic Kidney, Polycystic Kidney Disease, Fetal Renal Anomaly, Anhydramnios, Potter Syndrome, Lung Hypoplasia
- Being tested
- Amnioinfusion
- Keywords
- Fetal Renal Failure, Kidney Disease, MCDK, PCKD
- Medical subject headings
- Multicystic Dysplastic Kidney, Polycystic Kidney Diseases, Hereditary renal agenesis, Multicystic renal dysplasia, bilateral, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioinfusionOther
Also called Amniotic fluid injection
A 20- or 22-gauge spinal needle (routinely used obstetrics and gynecology needle) will be used by an expert in fetal procedures with sterile technique to access the amniotic cavity under real-time ultrasound guidance to infuse isotonic fluid (Lactated Ringers with 1g/L of Oxacillin). This fluid will act as replacement amniotic fluid. Regular monitoring of fluid levels may suggest serial infusion, which will be completed as deemed necessary by the study doctor.
| Study group | Role | What they receive |
|---|---|---|
| Amnioinfusion | Experimental | Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor. Receives: Other: Amnioinfusion |
| Comfort Care/Expectant Management | No intervention | The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Survival to Dialysis
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)
Measured: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.
Fetal Survival to Transplant
The proportion of neonates who survive to receive a kidney transplant following continuous, successful dialysis.
Measured: >=2 years after delivery.
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Maternal safety will be assessed by tracking adverse events, including bleeding, infections, and preterm rupture of membranes, at each visit, after procedures, and postpartum. These events will be documented at each prenatal visit, following every amnioinfusion, at delivery, and during a follow-up period of at least 30 days postpartum. The safety evaluation will focus on identifying procedure-related complications and ensuring the well-being of participants throughout the study.
Measured: From enrollment in the study through delivery and up to 30 days postpartum.
Secondary outcomes (5)
Number of infusions prior to rupture of membranes among participants in the intervention group
The practicality of performing serial amnioinfusions for early pregnancy renal anhydramnios will be evaluated by counting the number of infusions administered before rupture of membranes in the intervention group.
Measured: During the pregnancy, up to 9 months
Mean gestational age at rupture of membranes in the intervention group
The feasibility of serial amnioinfusions will be assessed by determining the average gestational age at which rupture of membranes occurs in the intervention group.
Measured: During the pregnancy, up to 9 months
Mean gestational age at delivery in the intervention group
The feasibility of serial amnioinfusions will be measured by calculating the mean gestational age at delivery among participants in the intervention group.
Measured: During the pregnancy, up to 9 months
Rate of fetal demise in utero among participants in the non-intervention group
An exploratory analysis will examine the natural progression of untreated early pregnancy renal anhydramnios by analyzing the rate of in utero fetal demise in the non-intervention group.
Measured: During the pregnancy, up to 9 months
Mean gestational age at delivery in the non-intervention group
An exploratory study will investigate the natural history of untreated early pregnancy renal anhydramnios by calculating the average gestational age at delivery for participants in the non-intervention group.
Measured: During the pregnancy, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start5 Dec 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multicystic Dysplastic KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fetal Care Center, PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical City Children's Hospital, Medical City Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728228
- Sponsor's protocol ID
- 2063654
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miller JL, Baschat AA, Rosner M, Blumenfeld YJ, Moldenhauer JS, Johnson A, Schenone MH, Zaretsky MV, Chmait RH, Gonzalez JM, Miller RS, Moon-Grady AJ, Bendel-Stenzel E, Keiser AM, Avadhani R, Jelin AC, Davis JM, Warren DS, Hanley DF, Watkins JA, Samuels J, Sugarman J, Atkinson MA. Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial. JAMA. 2023 Dec 5;330(21):2096-2105. doi: 10.1001/jama.2023.21153.
PubMed 38051327O'Hare EM, Jelin AC, Miller JL, Ruano R, Atkinson MA, Baschat AA, Jelin EB. Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. Fetal Diagn Ther. 2019;45(6):365-372. doi: 10.1159/000497472. Epub 2019 Mar 21.
PubMed 30897573
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnioinfusion for Fetal Renal Failure
- ClinicalTrials.gov ID
- NCT06728228
- Acronym / sponsor ID
- 2063654
- Conditions
- Multicystic Dysplastic Kidney, Polycystic Kidney Disease, Fetal Renal Anomaly, Anhydramnios, Potter Syndrome, Lung Hypoplasia
- Keywords
- Fetal Renal Failure, Kidney Disease, MCDK, PCKD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fetal Care Center, PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Medical City Children's Hospital, Medical City Women's Hospital
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are:
- Can serial amnioinfusion increase the chances of survival for these fetuses?
- Does this procedure improve chances of survival until dialysis and/or kidney transplant?
Participants will:
- Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity.
- Undergo monitoring to check the effects on the fetus and mother.
This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.
Detailed description
Fetal renal failure (FRF) is a severe and life-threatening condition caused by congenital abnormalities or inherited kidney diseases. In the womb, when the kidneys fail to function properly, this leads to a condition called anhydramnios-a complete lack of amniotic fluid. Amniotic fluid is essential for the fetus's lung development, particularly during the canalicular phase of pulmonary development, which occurs between 16 and 28 weeks of gestation. Without sufficient amniotic fluid, the lungs cannot develop properly, resulting in a condition known as pulmonary hypoplasia. Severe hypoplasia has previously been described as almost always fatal, typically leading to neonatal death shortly after birth.
In recent years, promising advances in fetal therapies have opened new doors for treating conditions that were once considered untreatable. One such intervention involves serial amnioinfusion, a procedure where sterile saline or another isotonic fluid is injected into the amniotic sac to restore fluid levels. Early studies, including the RAFT trial (Renal Anhydramnios Fetal Therapy), have demonstrated that this approach may improve survival rates by promoting lung development in fetuses with FRF. Building upon these findings, this study seeks to further evaluate the safety and effectiveness of serial amnioinfusion in improving neonatal outcomes for families facing this diagnosis.
This study will enroll approximately 60 pregnant individuals carrying singleton pregnancies complicated by FRF and anhydramnios. Participants will be divided into two groups: an intervention group, which will receive serial amnioinfusion procedures as deemed appropriate by the study doctor, and a control group, which will not undergo interventions and will receive comfort care for their pregnancies. The primary goals of the study are to evaluate maternal safety, assess fetal survival to dialysis, and determine survival to kidney transplant eligibility.
The amnioinfusion procedures will be performed at the Fetal Care Center by a team of experts in fetal procedures. To ensure patient safety, the study includes a rigorous monitoring plan to track any potential adverse events in real time. Data from imaging studies (e.g., ultrasound, echocardiogram, MRI) and laboratory biomarkers will be collected to evaluate fetal and maternal responses to the treatment. While the study focuses on improving outcomes for individual patients, it also has broader implications for science and society. By systematically analyzing the benefits and risks of serial amnioinfusion, this research could help refine treatment protocols and set the stage for new standards of care for FRF. For the families involved, participation in this study offers the possibility of improved survival for their children, with potential eligibility for life-saving kidney transplants in the future.
This study represents a critical step toward addressing a condition that has long been considered untreatable. Through collaboration, innovation, and rigorous research, the team aims to provide hope for families affected by FRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnioinfusion | Experimental | Other: AmnioinfusionThose in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor. |
| Comfort Care/Expectant Management | No intervention | –The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed anhydramnios before 22 weeks GA for patients with FRF.
- Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
- Confirmation that the expectant mother understands her options for management of the pregnancy.
- Age ≥18 years of age.
- Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
Key exclusion criteria (10 listed)
- Cervix less than 2.5 cm in length.
- No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).
- Other significant congenital anomalies in the fetus.
- Evidence of chorioamnionitis or abruptio placentae.
- Evidence of rupture of membranes or chorionic-amniotic separation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmnioinfusionAlso: Amniotic fluid injectionA 20- or 22-gauge spinal needle (routinely used obstetrics and gynecology needle) will be used by an expert in fetal procedures with sterile technique to access the amniotic cavity under real-time ultrasound guidance to infuse isotonic fluid (Lactated Ringers with 1g/L of Oxacillin). This fluid will act as replacement amniotic fluid. Regular monitoring of fluid levels may suggest serial infusion, which will be completed as deemed necessary by the study doctor. | Other | Amnioinfusion |
Primary outcome
Fetal Survival to Dialysis
Time frame: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.
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)
Fetal Survival to Transplant
Time frame: >=2 years after delivery.
The proportion of neonates who survive to receive a kidney transplant following continuous, successful dialysis.
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From enrollment in the study through delivery and up to 30 days postpartum.
Maternal safety will be assessed by tracking adverse events, including bleeding, infections, and preterm rupture of membranes, at each visit, after procedures, and postpartum. These events will be documented at each prenatal visit, following every amnioinfusion, at delivery, and during a follow-up period of at least 30 days postpartum. The safety evaluation will focus on identifying procedure-related complications and ensuring the well-being of participants throughout the study.
5 secondary outcomes
Number of infusions prior to rupture of membranes among participants in the intervention group
Time frame: During the pregnancy, up to 9 months
Mean gestational age at rupture of membranes in the intervention group
Time frame: During the pregnancy, up to 9 months
Mean gestational age at delivery in the intervention group
Time frame: During the pregnancy, up to 9 months
Rate of fetal demise in utero among participants in the non-intervention group
Time frame: During the pregnancy, up to 9 months
Mean gestational age at delivery in the non-intervention group
Time frame: During the pregnancy, up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 38051327Miller JL, Baschat AA, Rosner M, Blumenfeld YJ, Moldenhauer JS, Johnson A, Schenone MH, Zaretsky MV, Chmait RH, Gonzalez JM, Miller RS, Moon-Grady AJ, Bendel-Stenzel E, Keiser AM, Avadhani R, Jelin AC, Davis JM, Warren DS, Hanley DF, Watkins JA, Samuels J, Sugarman J, Atkinson MA. Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial. JAMA. 2023 Dec 5;330(21):2096-2105. doi: 10.1001/jama.2023.21153.
- Background: PubMed 30897573O'Hare EM, Jelin AC, Miller JL, Ruano R, Atkinson MA, Baschat AA, Jelin EB. Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. Fetal Diagn Ther. 2019;45(6):365-372. doi: 10.1159/000497472. Epub 2019 Mar 21.
- Renal Anhydramnios Fetal Therapy (RAFT) Trial WesbiteLink provided by the sponsor.
- Fetal Care Center - Amnioinfusion FAQLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnioinfusion in people with Multicystic Dysplastic Kidney and Polycystic Kidney Disease, run by Fetal Care Center, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin P Magee, M.D. ((972) 566-5600, kevin.magee@fetalcaredallas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Survival to Dialysis (time frame: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728228, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.