Actively Recruiting
PS-002 for the Treatment of IgA Nephropathy in Adults
Led by Purespring Therapeutics Limited · Updated on 2026-03-20
32
Participants Needed
11
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate safety, tolerability, and preliminary effectiveness following administration of PS-002 in adults with primary Immunoglobulin A (IgA) nephropathy. This will be a first-in-human study and will include participants at high risk of disease progression despite receiving current standard-of-care treatment. Participants will be monitored for up to one year after receiving PS-002 and invited to take part in a long-term follow-up study (total follow-up: 5 years).
CONDITIONS
Official Title
PS-002 for the Treatment of IgA Nephropathy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary IgA nephropathy confirmed by kidney biopsy
- Kidney biopsy within 36 months showing complement component 3 (C3) deposition, or a new biopsy during screening showing ongoing complement activity
- Proteinuria at screening with urine protein-to-creatinine ratio of at least 1 g/g or 24-hour urine protein of at least 1 g/24 h
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73m2
- Sitting systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg
- Receiving best supportive care for IgA nephropathy as per protocol requirements
You will not qualify if you...
- Nephrotic syndrome with urine protein >3.5 g/24 h and serum albumin <3.0 g/dL
- Secondary IgA nephropathy linked to gastrointestinal, liver, autoimmune, malignancy, or respiratory disorders
- Major concurrent non-IgAN disease preventing IgAN assessment
- History of malignancy or organ/bone marrow transplant
- Primary or secondary immunodeficiency including HIV or severe blood disorders
- Other significant medical conditions increasing procedure or anesthesia risk
- Liver enzymes (AST or ALT) >1.5 times upper normal limit
- Serious infection requiring intravenous antibiotics within 8 weeks prior to treatment
- Recent use of immunosuppressive or immunomodulatory drugs within 90 days (180 days for rituximab), including systemic corticosteroids over 7.5 mg/day prednisone equivalent
- Recent use of oral budesonide requiring 90-day washout before treatment
- Live or attenuated vaccine within 6 weeks prior to treatment
- Known sensitivity or intolerance to corticosteroids or hypersensitivity to study drug ingredients
- Prior treatment with PS-002 or other gene therapies, or participation in other investigational trials during this study
- Positive hepatitis B surface antigen or hepatitis C RNA
- Use of potentially hepatotoxic medications without stable dosing and monitoring for over 90 days prior to dosing
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
University of Miami Hospital
Miami, Florida, United States, 33136
Actively Recruiting
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
4
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
5
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
6
Leicester General Hospital
Leicester, Leicestershire, United Kingdom, LE5 4PW
Not Yet Recruiting
7
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
8
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
9
Cardiff and Vale University Health Board
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
10
Royal Infirmary of Edinburgh Clinical Research Facility
Edinburgh, United Kingdom, EH16 4SA
Not Yet Recruiting
11
The Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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