Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

ConditionIgA Nephropathy

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorNovelMed Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

NM8074
Drug
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Cohort 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio

Time frame

Up to Study Day 99

Secondary outcomes

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

Other outcomes

Change from Baseline or Percent Change from Baseline in Classical Pathway (CP) modulation

NM8074-mediated CP inhibition is measure via a complement CP ELISA-based assay measuring MAC formation.

Time frame

Up to Study Day 155

Change from Baseline or Percent Change from Baseline in Factor B levels

Time frame

Up to Study Day 155

Change from Baseline or Percent Change from Baseline in plasma concentration of NM8074

Time frame

Up to Study Day 155

Maximum plasma concentration (Cmax)

Time frame

Up to Study Day 155

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovelMed Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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