IgA Nephropathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNM8074
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.
Sponsors
NovelMed Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will enroll a planned total of 10 patients as subjects for the trial, with extra enrollment if needed, at the discretion of the Investigator. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥18 years of age at the time of consent. * A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2. * Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years. * All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines. * Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 * Female and male participates must agree to use contraceptives
Exclusion criteria
* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074. * Require dialysis or plasma exchange within 12 weeks prior to screening. * Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy. * History of bone marrow, hematopoietic stem cells, or solid organ transplantation. * Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer. * Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis). * Clinically significant abnormal ECG during screening. * Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections. * Has a currently active or known history of meningococcal disease or N. meningitidis infection. * Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes. * Pregnant, planning to become pregnant, or nursing female subjects. * Females with a positive pregnancy test result at Screening or on Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio | Up to Study Day 99 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline or Percent Change from Baseline in eGFR | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in Serum Creatinine | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in Hematuria | Up to Study Day 155 | Measured through red blood cells present in urine from urinalysis |
| Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine concentration ratio | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in Bb plasma levels | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in sC5b-9 plasma levels | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in UPCR | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in Tmax | Up to Study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in Cmax | Up to study Day 155 | — |
| Change from Baseline or Percent Change from Baseline AUC0-t | Up to study Day 155 | — |
| Change from Baseline or Percent Change from Baseline in CLr | 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. | Up to study Day 155 | 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. |
| 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 | Up to study Day 155 | 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 |
Contacts
CONTACTRekha Bansal, PhD
Outcome results
None listed