Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies (NCT03453619) | Clinical Trial Compass
CompletedPhase 2
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
United States21 participantsStarted 2018-02-26
Plain-language summary
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI)
* Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation
* IgAN: Prior biopsy results for C3 and C4d staining should be made available
* LN: Diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (Class III, IV or V, respectively) by renal biopsy. Subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes)
* Primary MN: PLA2R positive titer plus nephrotic range proteinuria (defined as uPCR \>2350 mg/g)
* C3G plus one of the following: Low serum C3 level or historical renal biopsy within the last 3 years
* Have proteinuria \>750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a).
* eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis
* Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppres…
What they're measuring
1
Part A: Change From Baseline in Proteinuria at Week 48
Timeframe: Baseline (Day 1) and Week 48
2
Part B: Change From Baseline in Proteinuria at Week 168
Timeframe: Baseline (Part A, Week 48) and Week 168