NCT01339468 (MAIN) is a Phase 4 clinical trial of Advagraf in Liver Transplantation, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01339468?

NCT01339468 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01339468?

Interventions in NCT01339468: Advagraf, Prograf, Prograf.

What condition does NCT01339468 study?

NCT01339468 studies Liver Transplantation.

Is NCT01339468 still recruiting?

NCT01339468 is currently completed. Last updated 19 July 2017.

Last reviewed 2017-07-19 · How we verify

NCT01339468: MAIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

Completed Phase 4 Last updated 19 July 2017

What this trial tests

Phase 4 trial testing Advagraf in Liver Transplantation in 100 participants. Completed in 27 May 2014.

Timeline

27 April 2011

Primary endpoint
27 May 2014

27 May 2014

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	27 April 2011
Primary completion	27 May 2014
Estimated completion	27 May 2014
Sites	1 location across South Korea

Drugs / interventions tested

Advagraf — full drug profile →
Prograf — full drug profile →
Prograf — full drug profile →

Conditions studied

Liver Transplantation — all drugs for Liver Transplantation →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Advagraf

Trials testing the same drug.

NCT03603548 — Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patient · NA · unknown
NCT03216447 — A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant · Phase 4 · unknown
NCT02251691 — Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant · Phase 4 · unknown
NCT02034747 — A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated Wi · Phase 4 · completed
NCT02268201 — A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus · Phase 4 · terminated

Other recruiting trials for Liver Transplantation

Currently open trials in the same condition.

NCT07157631 — Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial · NA · recruiting
NCT07123740 — Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors · NA · recruiting
NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
NCT06874296 — Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time · NA · recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01339468 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 19 July 2017

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/NCT01339468.

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