New drug shows promise for slowing kidney disease in IgA nephropathy
NCT ID NCT04716231
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests atacicept, a weekly injection, in 376 adults with IgA nephropathy (Berger's disease). The goal is to reduce protein in the urine and slow the loss of kidney function. Participants receive either atacicept or a placebo for about a year. The study is active but no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atacicept
- What this could lead to
- If it works, this could provide a new treatment option to slow kidney damage in people with IgA nephropathy.
- What could go wrong
- This is a late-stage trial, but results are not yet final. The drug may not prove effective enough or could have side effects. It is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 376 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form * Male or female of ≥18 years of age * Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period * Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years * eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening * Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg Key Exclusion Criteria: * IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis * Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period * Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening) * Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<30g/L in association with UPCR \>3.5 mg/mg * Renal or other organ transplantation prior to, or expected during the study * Concomitant chronic renal disease in addition to IgAN * Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) \>7.5% at screening * History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test * Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ORIGIN 3 Global Site Contact Information
Brisbane, California, 94005, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 10,000 kidneys under the microscope: registry maps IgA Nephropathy's course
- Microbes in the mouth and gut may hold clues to a common kidney disease
- Can a transplant drug tame stubborn kidney disease?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?
- Can a new injection slow kidney disease in children?