DM199 treatment for pregnancy complications
DM199 for Pregnancy Complications Phase II a Proof of Concept Trial Assessing DM199 As a Therapeutic for Preeclampsia and Fetal Growth Restriction
This study is testing whether a new treatment called DM199 can help pregnant women with preeclampsia and fetal growth restriction by improving blood flow and reducing blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | DiaMedica Therapeutics Inc Industry-sponsored |
| Locations | 1 site (Tygerberg, CapeTown) |
| Trial ID | NCT06875141 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of DM199, a recombinant tissue kallikrein, to treat preeclampsia and fetal growth restriction during pregnancy. The approach focuses on improving maternal vascular function and reducing blood pressure, which are critical in managing these conditions. By enhancing blood flow to the placenta, DM199 aims to alleviate complications associated with poor placental function. The trial will assess the safety and efficacy of DM199 in pregnant women diagnosed with these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with preeclampsia and/or fetal growth restriction, between 27 and 42 weeks of gestation.
Not a fit: Patients with severe complications of preeclampsia or significant underlying maternal health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for mothers and their babies affected by preeclampsia and fetal growth restriction.
How similar studies have performed: While the specific use of DM199 is novel, similar approaches targeting vascular function in pregnancy complications have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of preeclampsia and/or fetal growth restriction * Gestational age between 27 weeks 0 days and 42weeks 0 days * Viable singleton pregnancy * Admitted for inpatient hospital management Exclusion Criteria: * Severe complications of preeclampsia which include; * Eclampsia * Pulmonary edema * HELLP syndrome * Severe renal involvement * Cerebrovascular event is defined as an ischemic or hemorrhagic stroke associated with clinical symptoms and definitive signs on imaging and or a liver hematoma or rupture. * Placental abruption * Clinical infection e.g.. chorioamnionitis * Underlying maternal cardiac disease including a significant arrhythmia, a conduction abnormality or severe valvular disease or congenital or acquired heart disease * Significant maternal vascular disease e.g.. renal artery stenosis * Patient is unable, or unwilling to give consent, or is under the age of 18. * Suspicion or diagnosis of a major fetal anomaly or malformation or chromosomal abnormality. A major fetal anomaly is defined as anomalies or malformations that create significant medical problems for the neonate or that require specific surgical or medical management. * Established fetal compromise that necessitate surgent delivery * History of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization or familial angioedema * Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening * Women with an active malignancy
Where this trial is running
Tygerberg, CapeTown
- Preeclampsia Research Institute, Department of Obstetrics and Gynaecology, Stellenbosch University, — Tygerberg, CapeTown, South Africa (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.