Recruiting PHASE2 IgA Nephropathy

New treatment option for IgA Nephropathy

Official title Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

ClinicalTrials.gov ID: NCT06740526

What this study is testing

What is Sibeprenlimab?

Sibeprenlimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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
This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
  • 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 16 and older

You may be able to join if

  • Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
  • Source-verified kidney biopsy confirmed diagnosis of IgAN.
  • Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology...

You likely can't join if

  • Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
  • Participant has coexisting chronic kidney disease, other than IgAN.
  • Participant has a serum IgG value \<600 mg/dL at screening.
  • Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or...
  • Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
  • Participants who would be likely to require prohibited concomitant therapy during the trial.

The study team makes the final eligibility decision.

Where it's taking place

  • Denver, Colorado, United States
  • Boston, Massachusetts, United States
  • Dakota Dunes, South Dakota, United States
  • Houston, Texas, United States
  • Scarborough Village, Ontario, Canada

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, 16 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Denver, Colorado, United States; Boston, Massachusetts, United States; Dakota Dunes, South Dakota, United States; Houston, Texas, United States; Scarborough Village, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

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.