An Open-Label Extension Study of BION-1301 in IgA Nephropathy.

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label Extension (OLE) Study for Patients with Immunoglobulin A Nephropathy (IgAN) Who Participated in A Prior Clinical Study of BION-1301.

• IRAS ID

  1003398

• Contact name

• Sponsor organisation

  Chinook Therapeutics, Inc.

• Eudract number

  2020-003058-66

• Research summary

  This study has been developed for patients with IgAN who are currently or previously were on the main Study ADU-CL-19. IgAN is a kidney disease called immunoglobulin A nephropathy and currently no cure exists for IgAN.

  This study is intended to provide patients a longer dosing period of BION 1301, the study medication, if the patient and their Study Doctor determine it is in the patient’s best interest. The study will be conducted at approximately 20 sites in the United States and United Kingdom. A total of up to 20 patients will be enrolled in this study.

  The purpose of the study is to continue developing BION-1301 for the treatment of IgA nephropathy. This includes understanding what happens when the study medication is given over an extended period of time, possible side effects and how the study medication is absorbed (taken up), metabolised (chemically broken down), distributed through the body, and excreted (eliminated from the body).

  This study is intended to last for approximately 2 years for each participant and consists of up to 30 or 57 planned study visits depending on which treatment group a participant was assigned to in Study ADU-CL-19. If a participant requires a separate Screening Visit, up to an additional 42 days of study participation may be required.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0027

• Date of REC Opinion

  8 Mar 2021

• REC opinion

  Further Information Unfavourable Opinion