This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.
The proposed study, NM8074-IgAN-601, will enroll a planned total of 10 patients as subjects for the trial. All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
NM8074 will be administered as an intravenous infusion. All subjects will be administered 17 mg/kg of NM8074 intravenously weekly for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.
Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio
Time frame: Up to Study Day 99
Change from Baseline or Percent Change from Baseline in eGFR
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Serum Creatinine
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Hematuria
Measured through red blood cells present in urine from urinalysis
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine concentration ratio
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Bb plasma levels
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in sC5b-9 plasma levels
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in UPCR
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Tmax
Time frame: Up to Study Day 155
Change from Baseline or Percent Change from Baseline in Cmax
Time frame: Up to study Day 155
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Change from Baseline or Percent Change from Baseline AUC0-t
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in CLr
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in quality of life (QoL) Assessed via the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, Version 4.
The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale ranging from "Not at all" to "Very much so". All items are summed to create a single fatigue score with a range from 0 to 52 with a better quality of life indicated by a higher score.
Time frame: Up to study Day 155
Change from Baseline or Percent Change from Baseline in Quality of Life (QoL) Assessed via the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Scale (QLQ- C30), Version 3.0
All EORTC QLQ-C30 scales and single-item measures range from 0 to 100. This includes 3 symptom scales (fatigue, pain, nausea and vomiting), 5 functional scales (physical, role, cognitive, emotional, and social), single-item questions addressing symptoms like insomnia, dyspnea, loss of appetite, and others that are commonly reported by cancer patients, and the perceived financial impact of the disease. A higher score is associated with a greater quality of life for global health status
Time frame: Up to study Day 155