PreeclampsiaSAVENCT02923206
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
A study testing TheraSorb sFlt-1 adsorber in people with Preeclampsia, run by Miltenyi Biomedicine GmbH at 4 sites in 2 countries.
Trial summary
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- TheraSorb sFlt-1 adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2016to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and ≤45 years;
- Male or female;
- Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and practice two reliable methods of contraception throughout the study.
- Age >18 and ≤45 years ;
- Pregnant woman with pre-term preeclampsia
- sFlt-1/PlGF ratio ≥85 ;
- sFlt-1 level of ≥ 8000pg/mL
Who cannot join
- Dysfunction of cerebral nervous system and/or heart disease;
- History of preexisting chronic renal disease;
- Treatment with ACE inhibitors;
- Therapeutic full anticoagulation therapy prior to trial entry;
- Liver abnormalities;
- Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia;
Show all 46Show fewer
- Active hepatitis B, C, or tuberculosis infection or HIV infection
- Hypersensitivity to heparin and/or citrate;
- Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions;
- Known intolerance to extracorporeal procedures in general or towards one of the individual excipients or towards other supporting agents;
- Drug or alcohol abuse within the last 2 years;
- Lack of compliance of subject;
- History or diagnosis of severe periodontitis;
- Phase A and B
- Maternal exclusion criteria
- History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease;
- History of preexisting chronic renal disease (CKD stage >3a, eGFR ≤45ml/min/1.73m²);
- Treatment with ACE inhibitors;
- Therapeutic full anticoagulation therapy prior to trial entry;
- Signs or history of clinically significant cerebral nervous system dysfunction;
- History of clinically significant liver abnormalities;
- Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia;
- Active hepatitis B, C, tuberculosis infection or HIV-positive status;
- Any condition that the investigator deems a risk to the patient or fetus in completing the trial;
- Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions;
- Drug or alcohol abuse within the last 2 years;
- Lack of compliance of patient;
- Known intolerance to extracorporeal procedures in general or to one of the excipients or other supporting agents;
- Hypersensitivity to heparin and/or citrate;
- < 30 0/7 weeks of gestation and abnormal CTG and/or abnormal Ductus venosus Doppler flow,
- ≥30 0/7 weeks of gestation and Doppler evidence of umbilical artery Absent or Reversed End-Diastolic Velocity (AREDV);
- Various Placental exclusion criteria;
- Multiple pregnancy
- History or diagnosis of severe periodontitis
- Fetal exclusion criteria
- Any known trisomy;
- Amniotic fluid index <5cm (greatest single pocket <2cm);
- Estimated fetal weight <3rd percentile for gestational age;
- Fetus which are at high risk of heart disease;
- Fetus with congenital heart defect;
- Fetal signs of bleeding;
- Hydrops fetalis;
- Pathological fetal Doppler flow of the ductus venosus (absent A-wave in two measurements);
- Evidence of severe fetal malformations;
- Known infection of fetus;
- Known severe anemia.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Universitätsklinikum Köln
Cologne, 50937
Universitätsklinikum Leipzig
Leipzig, 04103
United Kingdom2 sites
Cambridge Clinical Trials Unit, Addenbrooke's Hospital
Cambridge, CB2 0QQ
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Oxford, OX3 9DU
About this study
Official title: Proof-of-Concept Trial on Selective Removal of the Antiangiogenic Factor Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) in Pregnant Women With Preeclampsia Via Apheresis Utilizing the Flt-1 Adsorption Column
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- TheraSorb sFlt-1 adsorber
- Keywords
- apheresis, pregnancy, pre-eclampsia, PE, sFlt-1, Pre-term
- Medical subject headings
- Pre-Eclampsia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSorb sFlt-1 adsorberDevice
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
| Study group | Role | What they receive |
|---|---|---|
| Phase 0 - healthy volunteers | Experimental | Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure. Receives: Device: TheraSorb sFlt-1 adsorber |
| Phase A - preeclampsia patients | Experimental | Phase A is a safety and dose-finding phase during which pregnant women diagnosed with preeclampsia will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure. Receives: Device: TheraSorb sFlt-1 adsorber |
| Phase B - preeclampsia patients | Experimental | Phase B is a safety and efficacy phase during which pregnant women diagnosed with preeclampsia will undergo TheraSorb sFlt-1 adsorber apheresis procedures up to twice weekly. Receives: Device: TheraSorb sFlt-1 adsorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
Measured: until 2 weeks post treatment
Occurrence of AEs and SAEs in pregnant subjects and the fetus or infant until the 6 weeks post-delivery visit is reached (Phase A-B).
Measured: until 6 weeks post delivery
Secondary outcomes (16)
Phase 0: Determine changes of sFlt-1 levels.
Measured: until 2 weeks post treatment
Phase 0: Complement activation levels pre-, during and post apheresis.
Measured: Before, during and directly following the performance of the single apheresis treatment (1 day)
Phase 0: Concentration of antibody leaching during an apheresis procedure
Measured: During an apheresis procedure (1 day)
Phase 0: Change of HAMA levels in pre- and post apheresis blood
Measured: until 2 weeks post treatment
Phase 0: Evaluate blood pressure values
Measured: until 2 weeks post treatment
Phase 0: Evaluate spot urine values
Measured: until 2 weeks post treatment
Phase A/B: Occurrence of SAEs in the one year follow-up period
Measured: until end of FU, (1 year)
Phases A/B: Evaluate antibody leaching in phase A.
Measured: During the performance of the single apheresis treatment in Phase A (1 day) as well as pre and 3hrs post apheresis
Phases A and B: Evaluate maternal sFlt-1 levels.
Measured: Constant measures throughout the trial until delivery (up to 19 weeks)
Phases A/B: Evaluate the sFlt-1/PlGF ratio.
Measured: Constant measures throughout the trial until delivery (up to 19 weeks)
Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth.
Measured: at birth
Phases A/B: Determine HAMA levels
Measured: until 6 week FU visit
Phases A/B: Time and method of delivery, and anesthesia administered
Measured: at birth
Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization.
Measured: Following birth up to one year
Phases A/B: Evaluate standard markers of fetal development throughout pregnancy.
Measured: From start of trial until delivery (up to 19 weeks)
Phases A/B: Evaluate standard markers of neonatal development.
Measured: Directly following delivery until end of FU (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion20 Aug 2024
- Study completion16 Jul 2025
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 PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cromsource
- Responsible party
- Sponsor
- Investigators
- Thomas Benzing, Prof. Dr., Principal investigator, University Clinic Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923206
- Sponsor's protocol ID
- M-2016-313
- Acronym
- SAVE
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thadhani R, Karumanchi SA. Transforming Preeclampsia Care: Molecular Diagnostics and Therapeutic Innovations. J Am Soc Nephrol. 2026 Jul 8. doi: 10.1681/ASN.0000001197. Online ahead of print.
PubMed 42418275Thadhani R, Hiemstra TF, Vatish M, Stepan H, Cerdeira AS, Brockelsby J, James T, Lia M, Cornelis A, Krause E, Spath MR, Gruttner B, Todorova P, Hagmann H, Yeung KR, Xu B, Heffernan S, Pears S, Waugh R, Thompson J, Iliopoulos J, Sunderland N, Killingsworth M, Makris A, Hennessy A, Lo A, Tan AY, Kussie P, Chang Y, Hanssens L, Miltenyi S, Benzing T, Karumanchi SA. Targeted removal of soluble Fms-like tyrosine kinase 1 in very preterm preeclampsia: a pilot trial. Nat Med. 2026 Jun;32(6):2173-2181. doi: 10.1038/s41591-026-04333-6. Epub 2026 Apr 27.
PubMed 42045577
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Trial on Selective Removal of the Antiangiogenic Factor Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) in Pregnant Women With Preeclampsia Via Apheresis Utilizing the Flt-1 Adsorption Column
- ClinicalTrials.gov ID
- NCT02923206
- Acronym / sponsor ID
- SAVE / M-2016-313
- Conditions
- Preeclampsia
- Keywords
- apheresis, pregnancy, pre-eclampsia, PE, sFlt-1, Pre-term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Cromsource
- Study start
- Sep 2016 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 0 - healthy volunteers | Experimental | Device: TheraSorb sFlt-1 adsorberPhase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure. |
| Phase A - preeclampsia patients | Experimental | Device: TheraSorb sFlt-1 adsorberPhase A is a safety and dose-finding phase during which pregnant women diagnosed with preeclampsia will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure. |
| Phase B - preeclampsia patients | Experimental | Device: TheraSorb sFlt-1 adsorberPhase B is a safety and efficacy phase during which pregnant women diagnosed with preeclampsia will undergo TheraSorb sFlt-1 adsorber apheresis procedures up to twice weekly. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤45 years;
- Male or female;
- Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and practice two reliable methods of contraception throughout the study.
- Age >18 and ≤45 years ;
- Pregnant woman with pre-term preeclampsia
Key exclusion criteria (46 listed)
- Dysfunction of cerebral nervous system and/or heart disease;
- History of preexisting chronic renal disease;
- Treatment with ACE inhibitors;
- Therapeutic full anticoagulation therapy prior to trial entry;
- Liver abnormalities;
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 |
|---|---|---|
| TheraSorb sFlt-1 adsorberRemoval of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis. | Device | Phase 0 - healthy volunteers, Phase A - preeclampsia patients, Phase B - preeclampsia patients |
Primary outcome
Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
Time frame: until 2 weeks post treatment
Occurrence of AEs and SAEs in pregnant subjects and the fetus or infant until the 6 weeks post-delivery visit is reached (Phase A-B).
Time frame: until 6 weeks post delivery
16 secondary outcomes
Phase 0: Determine changes of sFlt-1 levels.
Time frame: until 2 weeks post treatment
Phase 0: Complement activation levels pre-, during and post apheresis.
Time frame: Before, during and directly following the performance of the single apheresis treatment (1 day)
Phase 0: Concentration of antibody leaching during an apheresis procedure
Time frame: During an apheresis procedure (1 day)
Phase 0: Change of HAMA levels in pre- and post apheresis blood
Time frame: until 2 weeks post treatment
Phase 0: Evaluate blood pressure values
Time frame: until 2 weeks post treatment
Phase 0: Evaluate spot urine values
Time frame: until 2 weeks post treatment
Phase A/B: Occurrence of SAEs in the one year follow-up period
Time frame: until end of FU, (1 year)
Phases A/B: Evaluate antibody leaching in phase A.
Time frame: During the performance of the single apheresis treatment in Phase A (1 day) as well as pre and 3hrs post apheresis
Phases A and B: Evaluate maternal sFlt-1 levels.
Time frame: Constant measures throughout the trial until delivery (up to 19 weeks)
Phases A/B: Evaluate the sFlt-1/PlGF ratio.
Time frame: Constant measures throughout the trial until delivery (up to 19 weeks)
Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth.
Time frame: at birth
Phases A/B: Determine HAMA levels
Time frame: until 6 week FU visit
Phases A/B: Time and method of delivery, and anesthesia administered
Time frame: at birth
Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization.
Time frame: Following birth up to one year
Phases A/B: Evaluate standard markers of fetal development throughout pregnancy.
Time frame: From start of trial until delivery (up to 19 weeks)
Phases A/B: Evaluate standard markers of neonatal development.
Time frame: Directly following delivery until end of FU (1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42418275Thadhani R, Karumanchi SA. Transforming Preeclampsia Care: Molecular Diagnostics and Therapeutic Innovations. J Am Soc Nephrol. 2026 Jul 8. doi: 10.1681/ASN.0000001197. Online ahead of print.
- Derived from this study: PubMed 42045577Thadhani R, Hiemstra TF, Vatish M, Stepan H, Cerdeira AS, Brockelsby J, James T, Lia M, Cornelis A, Krause E, Spath MR, Gruttner B, Todorova P, Hagmann H, Yeung KR, Xu B, Heffernan S, Pears S, Waugh R, Thompson J, Iliopoulos J, Sunderland N, Killingsworth M, Makris A, Hennessy A, Lo A, Tan AY, Kussie P, Chang Y, Hanssens L, Miltenyi S, Benzing T, Karumanchi SA. Targeted removal of soluble Fms-like tyrosine kinase 1 in very preterm preeclampsia: a pilot trial. Nat Med. 2026 Jun;32(6):2173-2181. doi: 10.1038/s41591-026-04333-6. Epub 2026 Apr 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas Benzing, Prof. Dr. principal investigator
University Clinic Cologne
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSorb sFlt-1 adsorber in people with Preeclampsia, run by Miltenyi Biomedicine GmbH at 4 sites in 2 countries.
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 46 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: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0) (time frame: until 2 weeks post treatment). The study lists 2 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 NCT02923206, 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 30 Sep 2025.