Evaluating ARO-CFB in Healthy Adults and Patients with Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-CFB Injection in both healthy adult volunteers and patients suffering from IgA Nephropathy, a type of complement-mediated kidney disease. The trial is divided into two parts: the first part involves healthy volunteers receiving either ARO-CFB or a placebo, while the second part focuses on adult patients with IgAN receiving three open-label doses of ARO-CFB. The dosing for patients will be informed by the safety and pharmacodynamic data collected from the healthy volunteer phase.

Why it matters

Who can join: the full rules

Inclusion Criteria (All Participants):

* Willing to provide written informed consent and to comply with study requirements
* Female participants must be non-pregnant/non-lactating
* Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. IgAN participants must have been vaccinated or willing to undergo vaccination
* All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae type B
* Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or the last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later.
* No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.

Inclusion Criteria (IgAN Participants):

* Diagnosis of IgA Nephropathy based on renal biopsy within 5 years
* Clinical evidence of ongoing disease based on significant proteinuria
* Estimated glomerular filtration rate ≥30 mL/min/1.73m2 at Screening and currently not on dialysis
* Must have stable or worsening renal disease, on stable and optimized treatment for at least 30 days prior to Screening and willing to stay on a stable standard of care regimen for the duration of the study
* Must be on a maximally recommended or tolerated dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria (All Cohorts):

* History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
* History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
* Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* History of meningococcal infection
* History of asplenia
* History of severe aplastic anemia or concurrent severe aplastic anemia
* Known or suspected hereditary complement deficiency or other primary immunodeficiency syndrome
* History of diabetes mellitus (Type 1 or Type 2)
* Uncontrolled hypertension

Exclusion Criteria (IgAN Participants):

* Nephrotic syndrome or rapidly progressive glomerulonephritis
* Suspicion for secondary etiologies of IgAN
* Evidence of non-IgAN kidney disease on renal biopsy
* Renal biopsy showing interstitial fibrosis/tubular atrophy of more than 50%
* Use of complement inhibitors or monoclonal antibody therapies for treatment of IgAN

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Where it's running

• New Zealand Clinical Research OPCO Ltd
  Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: gshekhtman@arrowheadpharma.com
• Phone: 626-696-4702

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.