A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

Overview

About this study

The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). These patients are at high risk for progression of kidney disease, which can result in end-stage renal failure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Patients 18 - 65 years of age.
  • Diagnosed with primary IgAN.
  • Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or an ARB or a direct renin-inhibitor.
  • Has urine protein greater than or equal to 1 gram/24-hour. 
  • Has hematuria (blood cells present in urine).

Exclusion Criteria: 

  • Patients less than 18 years or older than 65 years old.
  • Has renal disease other than IgAN.
  • Has a diagnosis of rapidly progressive glomerulonephritis. 
  • Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis).
  • Has poor kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2. 
  • Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection.
  • Has on-going high blood pressure.
  • Treated with systemic corticosteroids or any immunosuppressant agents in the past 12 months .
  • Received an organ transplant.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Open for enrollment

Contact information:

Jessica O'Neill

(507)266-1047

ONeill.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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