Is NCT07182227 recruiting in Baltimore, MD?

Yes, NCT07182227 is currently recruiting participants at its Baltimore, MD location. This iga nephropathy clinical trial is actively enrolling qualified participants.

How do I join the iga nephropathy clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

IgA Nephropathy Clinical Trial in Baltimore, MD

About This IgA Nephropathy Study in Baltimore

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).

Sponsor: Purespring Therapeutics Limited

Who Can Participate

Inclusion 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 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 Criteria

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. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07182227) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

IgA Nephropathy Treatment Options in Baltimore, MD

If you're searching for iga nephropathy treatment options in Baltimore, MD, this clinical trial (NCT07182227) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced iga nephropathy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all iga nephropathy clinical trials near you to find additional studies recruiting in your area.

IgA Nephropathy Clinical Trial in Baltimore, MD

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