PS-002 for IgA Nephropathy
This study is testing a new treatment called PS-002 for adults with IgA nephropathy (a kidney disease where antibodies called IgA build up in the kidneys). PS-002 is a gene therapy that delivers a specific gene (Complement Factor I) to your body. This is the first time PS-002 is being given to people. The study aims to see how safe PS-002 is, if people can tolerate it, and if it shows early signs of working. You might be able to join if you have IgA nephropathy, have had a kidney biopsy showing C3 deposition, and are at high risk of your disease getting worse even with current treatments. The main goal is to track any side effects from PS-002 for up to 48 weeks. The study is currently recruiting about 32 participants.
- Study design
- This is an interventional study, meaning participants will receive a treatment. It is a first-in-human study and plans to enroll 32 participants.
- What's involved
- Participants will be monitored for up to one year after receiving PS-002. They will also be invited to participate in a long-term follow-up study for a total of 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for up to one year after receiving PS-002, with a total follow-up period of 5 years if they join the long-term study.
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NCT07182227
PS-002 for the Treatment of IgA Nephropathy in Adults
Recruiting
PHASE1Ages 18+InterventionalTreatmentPurespring Therapeutics Limited
~32 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:PS-002
At a glance
Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with: Treatment-Emergent Adverse Events (TEAEs) and serious TEAEs, TEAEs and serious TEAEs related to PS-002, TEAEs and serious TEAEs related to the PS-002 administration procedure
Measured over Screening up to Week 48
Conditions
Where it's being run
10 sites across 6 statesUnited Kingdom4
Greater Manchester2
Florida1
Maryland1
Leicestershire1
Nottinghamshire1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of primary IgA nephropathy (IgAN) as evidenced by renal biopsy.
A historic kidney biopsy performed within 36 months prior to screening with reported evidence of complement component 3 (C3) deposition. If the participant had a kidney biopsy performed over 36 months prior to Screening, a new kidney biopsy should be carried out during the Screening period. This biopsy must exhibit signs of ongoing complement system activity.
Proteinuria as assessed at the Screening visit by UPCR at least 1g/g (at least 1000 mg/g) OR total protein excretion at least 1 g/24 h (at least 1000 mg/24h) sampled from 24 h urine collection.
eGFR calculated using the CKD-EPI formula at least 45 mL/min/1.73m\^2.
Sitting office systolic blood pressure equal to or less than 140 mmHg, diastolic blood pressure equal to or less than 90 mmHg.
All participants must have been on best supportive care for IgAN, as per region-specific requirements defined in the protocol.
Exclusion
A participant has nephrotic syndrome, defined for this purpose as 24 h urine protein greater than 3.5g with concurrent hypoalbuminemia (serum albumin less than 3.0 g/dL \[less than 30 g/L\]).
Any secondary IgAN defined as associated with gastrointestinal and liver disorders (liver cirrhosis, celiac disease, Crohn's disease, ulcerative colitis), autoimmune disorders (dermatitis herpetiformis, psoriasis, seronegative arthritis, systemic lupus erythematosus, rheumatoid arthritis), malignancy (IgA myeloma, lymphoma, lung cancer, renal cell cancer, cutaneous T-cell lymphoma), respiratory disorders (bronchiolitis obliterans, idiopathic pulmonary fibrosis) etc.
Having a major concurrent non-IgAN-related disease that, in the opinion of the investigator, prevents the assessment of IgAN.
History of malignancy; or bone marrow or organ transplant.
History of, or currently active primary or secondary immunodeficiency, including known history of human immunodeficiency virus infection, and other severe immunodeficiency blood disorders.
Presence of other significant medical conditions that would create an unacceptable procedure or anesthesia risk.
Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the upper limit of normal.
History of serious infection requiring parenteral antibiotics within the past 8 weeks prior to study drug administration.
Participants previously treated with immunosuppressive/immunomodulatory agents such as, but not limited to, cyclophosphamide, infliximab, complement inhibitor, canakinumab, mycophenolate mofetil, mycophenolate sodium, cyclosporine, tacrolimus, everolimus, or systemic corticosteroids (exposure greater than 7.5mg/day prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to Screening. Participants previously or currently receiving oral budesonide (Kinpeygo/Tarpeyo) require wash out for 90 days prior to the study drug administration.
Exposed to a live or attenuated vaccine within the 6 weeks prior to study drug administration.
Participants with a known sensitivity or intolerance to corticosteroid therapy.
Known hypersensitivity to study drug ingredients.
Prior treatment with PS-002 or any other gene therapy, or participation in any other investigational trial during this study.
Positive serology for hepatitis B or C, i.e., positive hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) viral load positive.
Participants treated with potentially hepatotoxic medications unless they have been monitored in accordance with the drug label and have received a stable dose since \>90 days prior to dosing without clinically significant liver enzyme fluctuations.
What this trial measures
- Number of participants with: Treatment-Emergent Adverse Events (TEAEs) and serious TEAEs, TEAEs and serious TEAEs related to PS-002, TEAEs and serious TEAEs related to the PS-002 administration procedureScreening up to Week 48