Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.

Trial Profile

Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2022

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Tacrolimus (Primary)
  • Indications Renal transplant rejection
  • Focus Registrational; Therapeutic Use
  • Sponsors Veloxis Pharmaceuticals
  • Most Recent Events

    • 10 Jul 2015 According to a Veloxis Pharmaceuticals media release, Envarsus XR [tacrolimus extended-release] has been approved by the U.S. FDA for the prevention of kidney transplant rejection in patients who require conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. The approval is based on the review from this and another phase III trial [see CT profile 70052120] as well as several phase II trials.
    • 03 Mar 2015 According to a Veloxis Pharmaceuticals media release, the FDA has accepted for standard review the company's NDA for Envarsus for the prevention of organ rejection in adult kidney transplant patients.
    • 28 Jul 2014 According to a Veloxis Pharmaceuticals media release, marketing authorization has been granted to tacrolimus (Envarsus) based on this and another phase III trial (see profile 70052120) as well as data from an extensive Phase I and II clinical program.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top