Health Condition 1: D593- Hemolytic-uremic syndrome
Conditions
Interventions
Intervention1: Coversin (rVA576) powder for solution for subcutaneous injection 18 mg/vial: Powder for solution for injection, Subcutaneous route of administration , Duration-02 Years
Control Interven
Sponsors
Akari Therapeutics Plc
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years and older at the time of consent 2. LDH at screening or at the onset of the current aHUS episode was >= 1.5 ULN 3. Platelet count at screening 4. Evidence of AKI as per KDIGO guidelines. 5. Males and females of childbearing potential must agree to use an adequate method of contraception. Females will have a negative serum pregnancy test before entry to the study and throughout the study. Women of child-bearing potential are considered to remain so following menarche until becoming post-menopausal unless permanently sterilised. Permanent sterile methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative cause. 6. The patient has given voluntary written informed consent 7. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the KDIGO guidelines and local standard of care of the PI at each trial site 8. The patient is willing to comply with the process of preparation and self-administration of the study drug
Exclusion criteria
Exclusion criteria: 1. Thrombotic Thrombocytopenic Purpura (TTP), defined as ADAMTS13 activity 2. Typical HUS (known Shiga toxin + or positive EHEC culture) 3. HUS related to known HIV infection 4. Identified drug exposure-related HUS 5. HUS related to bone marrow transplant (BMT) 6. HUS related to Cobalamin (vitamin B12) deficiency 7. Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive 8. Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease 9. Unresolved meningococcal disease 10. Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome 11. Prior use of eculizumab (Soliris®) within 2 months of screening is prohibited 12. Exposure to any other investigational drug acting directly on the complement system within 5 half-lives of screening is prohibited 13. Chemotherapeutic agents within 3 months of enrolment in the study are prohibited 14. History of malignancy within 5 years of screening 15. Known sensitivity to the excipients of meningococcal vaccines, ciprofloxacin or any other antibiotic being administered for purposes of meningitis prophylaxis 16. Participation in other clinical trials within 4 weeks of signing the ICF 17. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with Normal Platelet count at Day 180Timepoint: Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete TMA response with preserved renal function and improved renal function. Proportion of subjects with TMA event free status. Time to complete TMA response with improved renal function. Platelet mean count change.Proportion of subjects with Hematologic Normalization.Proportion of subjects with normalisation of platelet count.Proportion of subjects with improvement in renal function.Reduction in requirement for Dialysis. Major Adverse Vascular Events (MAVE) rate.Safety for Coversin.Timepoint: Day 30, Day 60, Day 90, Day120, Day 150, Day 180. | — |
Countries
France, Germany, India, United Kingdom
Contacts
Public ContactDr Preeti Kabra
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed