NCT01371344 (PROGRESSION) is a Phase 4 clinical trial of Tacrolimus granules in Heart Transplantation, sponsored by Astellas Pharma Europe Ltd..

Who is sponsoring NCT01371344?

NCT01371344 is sponsored by Astellas Pharma Europe Ltd..

What drugs are being tested in NCT01371344?

Interventions in NCT01371344: Tacrolimus granules, Tacrolimus capsules.

What condition does NCT01371344 study?

NCT01371344 studies Heart Transplantation, Kidney Transplantation, Liver Transplantation.

Is NCT01371344 still recruiting?

NCT01371344 is currently terminated. Last updated 1 November 2024.

Last reviewed 2024-11-01 · How we verify

NCT01371344: PROGRESSION

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

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

Terminated Phase 4 Last updated 1 November 2024

What this trial tests

Phase 4 trial testing Tacrolimus granules in Heart Transplantation in 47 participants. Terminated before completion.

Timeline

24 June 2011

Primary endpoint
2 April 2017

2 April 2017

Quick facts

Lead sponsor	Astellas Pharma Europe Ltd.
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	47
Start date	24 June 2011
Primary completion	2 April 2017
Estimated completion	2 April 2017
Sites	12 locations across France, Belgium, United Kingdom, Germany, Poland, Spain

Drugs / interventions tested

Tacrolimus granules
Tacrolimus capsules — full drug profile →

Conditions studied

Heart Transplantation — all drugs for Heart Transplantation →
Kidney Transplantation — all drugs for Kidney Transplantation →
Liver Transplantation — all drugs for Liver Transplantation →

Sponsor

Astellas Pharma Europe Ltd. — full company profile →

Who can join

Adults 0 to 12, any sex, with Heart Transplantation or Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

Publications & conference data

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

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
Hill KD, Henderson HT, Hornik CP, Li JS. · · 2015 · cited 9× · PMID 26377725 · DOI 10.1017/s1047951115000980

Verify or expand the search:

Other trials of Tacrolimus granules

Trials testing the same drug.

NCT05152628 — A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo · Phase 4 · completed
NCT05153915 — A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograf · Phase 4 · completed
NCT01371331 — A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transpl · Phase 4 · completed

Other recruiting trials for Heart Transplantation

Currently open trials in the same condition.

NCT07359690 — Multimodal Analysis of Endomyocardial Biopsies · recruiting
NCT07096973 — Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery · recruiting
NCT07372820 — METABolic Deterioration in HTX Determines Outcomes · recruiting
NCT06982404 — ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biop · recruiting
NCT07531784 — A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplan · recruiting

Other Astellas Pharma Europe Ltd. trials

Trials by the same sponsor.

NCT07455812 — A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Men · active not recruiting
NCT05300568 — A Survey About Trade-offs When Choosing Menopause Treatments · completed
NCT05015998 — A Study to Evaluate the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using · completed
NCT05083884 — A Survey About Hot Flashes in Women Going Through the Menopause · completed
NCT04042350 — Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk · 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 NCT01371344 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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 Europe Ltd.
Last refreshed: 1 November 2024

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/NCT01371344.

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