Health TrialsbyHealthPanel

Atacicept in Multiple Glomerular Diseases

ConditionspMNIgANNephrotic SyndromeMCDFSGS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorVera Therapeutics, Inc.

About this trial

A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Weight of at least 40 kg

On a stable prescribed standard of care (SoC) treatment regimen according to local guidelines and the specific requirements for each disease

Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening.

Age ≥ 18 years

Disqualifiers

Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening)

Active viral or bacterial infections

Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study

Administration of live and live-attenuated vaccinations within 30 days prior to enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • Atacicept

    Drug

    Atacicept 150 mg SC QW via pre-filled syringe

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: IgAN or IgAVNExperimental treatment 1 intervention
Group B: pMNExperimental treatment 1 intervention
Group C: Primary Nephrotic Syndrome (MCD/FSGS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AE profile and results of routine clinical and laboratory tests

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs

Time frame
Baseline until end of study: 52 + 26 Weeks
2

Percent reduction in urine protein to creatinine ratio (UPCR)

Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36

Time frame
Baseline, Week 36

Secondary outcomes

1

Changes from baseline estimated glomerular filtration rate (eGFR).

Changes from baseline in estimated glomerular filtration rate (eGFR).

Time frame
Baseline, Week 36, Week 52
2

Change in disease-specific antibodies

IgAN: Percent change from baseline galactose-deficient IgA1 (GdIgA1) levels at 36 and 52 weeks. pMN: Percent change from baseline in anti-PLA2R antibody levels at 4, 8, 12, 36, and 52 weeks. MCD/FSGS: Percent change from baseline anti-nephrin antibody levels at 4, 8, 12, 36, and 52 weeks (exploratory).

Time frame
Baseline through 52 Weeks

Other outcomes

Sponsors and contacts

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

Vera Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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