Renal Failure CongenitalPhase 1NCT03723564
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
A Phase 1 study testing Lactated Ringers Solution for Injection in people with Renal Failure Congenital and Congenital Renal Anomaly Nos, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Failure Congenital, Congenital Renal Anomaly Nos, Renal Agenesis and Dysgenesis
- What is being tested?
- Lactated Ringers Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Dec 2029
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
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
Mayo Clinic
Rochester, Minnesota, 55905
Maureen A Lemens, BSN, RN, 507.293.1487, lemens.maureen@mayo.edu
Mauro Schenone, MD
About this study
Official title: Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies- a Feasibility Study
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.
Read more
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.
Read the detailed description
All women with fetuses having either severe LUTO with intrauterine renal failure or bilateral renal agenesis that meet the inclusion criteria will be invited to participate in this study. For those patients, the actual standard of care is expectant prenatal management or termination of pregnancy (<22 weeks according to law). This study will offer serial amnioinfusions for patients with LUTO or bilateral renal agenesis. Due to the rarity and complexity of these cases, the investigators expect to enroll a maximum of 5 women with affected fetuses per year. After two years (approximately 10 cases), a review of the data will be completed including all outcomes to determine whether to continue towards the original goal of treating 40 patients (20 mothers with affected fetuses) or to close the study,.
All procedures are anticipated to take place in the Family Birth Center at Mayo Clinic, Rochester. Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks. This procedure will be performed in a sterile fashion within the operating room using the same technique that is routinely used to perform the ultrasound-guided amnioinfusion. Once consented, weekly ultrasound monitoring will be conducted and if the amniotic fluid index (AFI) is determined to be <2 cm, amnioinfusion will proceed. Prior to each infusion, 5mLs of amniotic fluid will be collected to study surrogate markers of lung function (research only). Using a 22-gauge needle, warm sterile lactated ringer solution will be infused into the amniotic cavity until the AFI is equal to 8 cm. Some studies have demonstrated that the composition of the amniotic fluid during second and third trimester is closer to the lactated ringer solution. This procedure will be continued weekly until the fetus reaches 34 weeks, after which only monitoring will occur. If preterm premature rupture of the membranes (PPROM) occurs prior to 34 weeks, no further amnioinfusion procedures will be performed. Patients with PPROM will be managed according to the standardized clinical management. The anticipated length of stay in the hospital after each infusion is approximately 2 days if no uterine contractions are observed.
The prenatal care, delivery and postnatal management of the infant will be conducted according to the standardized clinical care. Delivery will be scheduled at the Mayo Clinic Family Birth Center and the infants will be followed for 24 months by the multi-specialty team as part of the standard clinical management including follow-up with neonatologist (NICU team), pediatric nephrology and transplant team according to the clinical protocol for postnatal renal replacement therapy and transplant. Neurodevelopment of the children will assessed using a combination of clinical examination and the Bayley Scale of Infant Development during the first 24 months of life.
- Conditions
- Renal Failure Congenital, Congenital Renal Anomaly Nos, Renal Agenesis and Dysgenesis, Lower Urinary Tract Obstructive Syndrome
- Being tested
- Lactated Ringers Solution for Injection
- Keywords
- bilateral renal agenesis, lower urinary tract obstruction, congenital renal anomalies, fetal surgery, amnioinfusion, fetus
- Medical subject headings
- Hereditary renal agenesis, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringers Solution for InjectionDrug
Also called Lactated Ringers Solution for Infusion
Using ultrasound guidance, a 22 gauge needle will be introduced into amniotic cavity. Warmed Lactated Ringers solution will be injected into the amniotic cavity until an AFI of 8.0 cm is achieved
| Study group | Role | What they receive |
|---|---|---|
| Amnioinfusion | Experimental | Lactated Ringers Solution for Injection --- Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks. Receives: Drug: Lactated Ringers Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Total number of Adverse Events experienced
Measured: First amnioinfusion through delivery which may be up to 22 weeks.
Secondary outcomes (2)
Survival to renal transplant
Number of subjects able to receive renal transplant.
Measured: 5 years
Survival to dialysis
Number of subjects able to receive dialysis
Measured: From time of birth up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure CongenitalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723564
- Sponsor's protocol ID
- 17-007726
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2018
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies- a Feasibility Study
- ClinicalTrials.gov ID
- NCT03723564
- Acronym / sponsor ID
- 17-007726
- Conditions
- Renal Failure Congenital, Congenital Renal Anomaly Nos, Renal Agenesis and Dysgenesis, Lower Urinary Tract Obstructive Syndrome
- Keywords
- bilateral renal agenesis, lower urinary tract obstruction, congenital renal anomalies, fetal surgery, amnioinfusion, fetus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Oct 2018 (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.
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.
Detailed description
All women with fetuses having either severe LUTO with intrauterine renal failure or bilateral renal agenesis that meet the inclusion criteria will be invited to participate in this study. For those patients, the actual standard of care is expectant prenatal management or termination of pregnancy (<22 weeks according to law). This study will offer serial amnioinfusions for patients with LUTO or bilateral renal agenesis. Due to the rarity and complexity of these cases, the investigators expect to enroll a maximum of 5 women with affected fetuses per year. After two years (approximately 10 cases), a review of the data will be completed including all outcomes to determine whether to continue towards the original goal of treating 40 patients (20 mothers with affected fetuses) or to close the study,.
All procedures are anticipated to take place in the Family Birth Center at Mayo Clinic, Rochester. Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks. This procedure will be performed in a sterile fashion within the operating room using the same technique that is routinely used to perform the ultrasound-guided amnioinfusion. Once consented, weekly ultrasound monitoring will be conducted and if the amniotic fluid index (AFI) is determined to be <2 cm, amnioinfusion will proceed. Prior to each infusion, 5mLs of amniotic fluid will be collected to study surrogate markers of lung function (research only). Using a 22-gauge needle, warm sterile lactated ringer solution will be infused into the amniotic cavity until the AFI is equal to 8 cm. Some studies have demonstrated that the composition of the amniotic fluid during second and third trimester is closer to the lactated ringer solution. This procedure will be continued weekly until the fetus reaches 34 weeks, after which only monitoring will occur. If preterm premature rupture of the membranes (PPROM) occurs prior to 34 weeks, no further amnioinfusion procedures will be performed. Patients with PPROM will be managed according to the standardized clinical management. The anticipated length of stay in the hospital after each infusion is approximately 2 days if no uterine contractions are observed.
The prenatal care, delivery and postnatal management of the infant will be conducted according to the standardized clinical care. Delivery will be scheduled at the Mayo Clinic Family Birth Center and the infants will be followed for 24 months by the multi-specialty team as part of the standard clinical management including follow-up with neonatologist (NICU team), pediatric nephrology and transplant team according to the clinical protocol for postnatal renal replacement therapy and transplant. Neurodevelopment of the children will assessed using a combination of clinical examination and the Bayley Scale of Infant Development during the first 24 months of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amnioinfusion | Experimental | Drug: Lactated Ringers Solution for InjectionLactated Ringers Solution for Injection --- Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Lactated Ringers Solution for InjectionAlso: Lactated Ringers Solution for InfusionUsing ultrasound guidance, a 22 gauge needle will be introduced into amniotic cavity. Warmed Lactated Ringers solution will be injected into the amniotic cavity until an AFI of 8.0 cm is achieved | Drug | Amnioinfusion |
Primary outcome
Adverse Events
Time frame: First amnioinfusion through delivery which may be up to 22 weeks.
Total number of Adverse Events experienced
2 secondary outcomes
Survival to renal transplant
Time frame: 5 years
Survival to dialysis
Time frame: From time of birth up to one month
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 6 Nov 2026.
- Mayo Clinic Clinical TrialsLink 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.
Mauro Schenone, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactated Ringers Solution for Injection in people with Renal Failure Congenital and Congenital Renal Anomaly Nos, run by Mayo Clinic 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 8 inclusion and 9 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 6 Nov 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Taylor M Rasmusson, MSN (507-266-4813, Rasmusson.Taylor@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: First amnioinfusion through delivery which may be up to 22 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.