BESTOW-EXTENSION

• Research type

  Research Study

• Full title

  BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

• IRAS ID

  1009614

• Contact name

  Trial Department

• Contact email

  clinicaltrials@eledon.com

• Sponsor organisation

  Eledon Pharmaceuticals, Inc.

• Clinicaltrials.gov Identifier

  NCT06126380

• Research summary

  This is an ‘extension study’. To be considered for this study patients must have already participated in a 1-year study of the safety and efficacy of tegoprubart for kidney transplant recipients.

  This research study is expected to enrol most of the participants already taking part in the parent studies AT-1501-K207 or AT-1501-K102. The maximum number of participants that these studies could therefore enrol globally is around 144.

  In this extension study, the Sponsor, Elendon Pharmaceuticals, Inc., would like to evaluate the long-term safety and efficacy of the investigational medication tegoprubart.

  The purpose of this extension study is to assess the long term safety of tegoprubart, in combination with the same standard immunosuppressive medicine, mycophenolate that the patients are already receiving. The study will also look at the function of the implanted kidney and will also assess how well tegoprubart prevents diabetes and prevents rejection.
  
  Participants will continue with the same treatment they were receiving in the parent study for an additional 48 months (around 4 years). If in the parent study the participant was receiving tegoprubart, it will continue to be administered as a 1-hour intravenous (IV) infusion at the study site every 21 days. Alternatively if in the parent study the participant was receiving the comparator medication, tacrolimus, this treatment will continue to taken as a capsule by mouth twice per day.

  As part of the extension study, the following procedures will be performed: Vital Signs and weight, collection of blood and urine samples, questionnaire completion, physical examination, administration of study medication (same regimen as the patient received on the parent study).

  In some cases, patients may be also asked to undergo a kidney biopsy, as part of their normal care.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  24/LO/0293

• Date of REC Opinion

  17 May 2024

• REC opinion

  Further Information Favourable Opinion