A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBio-Thera Solutions
About this trial
This is a phase II/III multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of BAT4406F injection in patients with Minimal Change Disease/Focal Segmental Glomerulosclerosis
Eligibility criteria
Qualifiers
Clinically diagnosed with NS, with a pathological diagnosis of Minimal change disease/Focal segmental glomerulosclerosis confirmed by renal biopsy within 7 years (Minimal change disease) or 10 years (Focal segmental glomerulosclerosis) prior to screening, and who are responsive to corticosteroid therapy
The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline
Disqualifiers
Secondary Nephrotic Syndrome
Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome
Receipt of any B-cell depletion or B-cell-modifying therapy within 6 months prior to baseline
History of allergy to monoclonal antibodies; or a predisposition to allergies
Trial design
Treatments tested in this trial
- BAT4406F
- Placebos
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov