Last reviewed · How we verify

NCT01680952

Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

Completed Phase 4 Last updated 7 March 2016
What this trial tests

Phase 4 trial testing A) TEST in Kidney Transplant Patients in 158 participants. Completed in 1 January 2016.

Timeline
1 September 2012
Primary endpoint
1 January 2016
1 January 2016

Quick facts

Lead sponsorYonsei University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment158
Start date1 September 2012
Primary completion1 January 2016
Estimated completion1 January 2016
Sites7 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

20 and older, any sex, with Kidney Transplant Patients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial.
    Huh KH, Lee JG, Ha J, Oh CK, et al · · 2017 · cited 16× · PMID 28810721 · DOI 10.1093/ndt/gfx093

Verify or expand the search:

Other recruiting trials for Kidney Transplant Patients

Currently open trials in the same condition.

Other Yonsei University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01680952.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing