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New treatment option for Immunoglobulin A (IgA) Nephropathy
Official title PS-002 for the Treatment of IgA Nephropathy in Adults
ClinicalTrials.gov ID: NCT07182227
What this study is testing
What is PS-002?
PS-002 is an investigational medicine, being studied as a potential treatment for immunoglobulin a (iga) nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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.
You likely can't join if
- A participant has nephrotic syndrome, defined for this purpose as 24 h urine protein greater than 3.5g with concurrent hypoalbuminemia (serum albumin...
- Any secondary IgAN defined as associated with gastrointestinal and liver disorders (liver cirrhosis, celiac disease, Crohn's disease, ulcerative...
- 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...
- Presence of other significant medical conditions that would create an unacceptable procedure or anesthesia risk.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Manchester, Greater Manchester, United Kingdom
- Leicester, Leicestershire, United Kingdom
- Nottingham, Nottinghamshire, United Kingdom
- Bristol, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Baltimore, Maryland, United States; Manchester, Greater Manchester, United Kingdom; Leicester, Leicestershire, United Kingdom; Nottingham, Nottinghamshire, United Kingdom; Bristol, United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.