STEADY study

• Research type

  Research Study

• Full title

  MULTICENTRE, OPEN LABEL, RANDOMIZED, TWO-ARM, PARALLEL-GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF ENVARSUS® COMPARED WITH TACROLIMUS USED AS PER CURRENT CLINICAL PRACTICE IN THE INITIAL MAINTENANCE SETTING IN DE NOVO KIDNEY TRANSPLANT PATIENTS.

• IRAS ID

  174242

• Contact name

  Richard Baker

• Contact email

  richard-j.baker@nhs.net

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2014-004314-29

• Clinicaltrials.gov Identifier

  RENA 4197, NIHR CRN

• Duration of Study in the UK

  1 years, 4 months, 25 days

• Research summary

  Renal transplantation is the best treatment for patients with endstage renal failure(ESRD).Transplantation has been made possible by the advances made in immunosuppressants such as Envarsus® which prevent the body's natural reaction to foreign tisusse and prevent graft rejection.

  Since its approval in 1994, tacrolimus, a Calcineurin Inhibitor (CNI), is now used in the majority of kidney transplant patients as the main component of immunosuppressive regimens. Envarsus® is convenient for patients since it is a once daily formulation of tacrolimus .
  Marketed formulations of tacrolimus exhibit variation in absorption and metabolism. Because of this variability standard dosing is not an accurate predictor of drug exposure; therefore trough level concentration (determined in a whole blood sample) is used in the clinical practice as an acceptable surrogate measure of exposure (area under the curve, AUC) with the aim of ensuring adequate immunosuppressive coverage.

  A recently completed study (3002) has shown that the treatment with the innovative once daily formulation of tacrolimus, Envarsus®, was associated with a lower percentage of de novo renal transplant patients with trough below therapeutic
  threshold in the first week after transplant as compared with Prograf. Furthermore, Envarsus® provided the same therapeutic efficacy as Prograf, but with a lower total daily dose of tacrolimus.

  Approximately 400 patients under going renal transplant will be enrolled into the study from centres in 11 European countries and will be in the study for 6 months completing 15 visits. Study visits will include blood samples, heart tracings, diary cards and physical examinations,Patients will be randomised to receive either Envarsus® extended release tablets once daily orally or Advagraf/Prograf as per sites normal practice.

  This is an open label randomised study conducted by Chiesi Farmaceutici S.p.A

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  15/YH/0295

• Date of REC Opinion

  9 Sep 2015

• REC opinion

  Further Information Favourable Opinion