Loading clinical trials...

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

NCT01371344•Astellas Pharma Europe Ltd.

View on ClinicalTrials.gov

Summary

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).

Detailed Description

To monitor the safety and efficacy of Modigraf® (tacrolimus granules) in stable paediatric allograft recipients (Part A) and to monitor dose changes and tacrolimus whole blood trough levels after conversion from a Modigraf based Immunosuppression regimen to a Prograf® based Immunosuppression regimen (Part B).

Eligibility

Age

0 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•F506-CL-0404 Part A
•Subject was ≤12 years of age at enrolment into study F506-CL-0403
•Subject received at least one dose of Modigraf in the F506-CL-0403 study
•F506-CL-0404 Part B
•Subject received at least one dose of Modigraf in the F506-CL-0403 study
•Subject participated in F506-CL-0404 Part A
•Subject has continuously been dosed with Twice daily (BID) Modigraf since the End of Study Visit for Part A (ESVA) from F506-CL-0404 Part A
•Subject is stable and has had no dose changes in the preceding 2 weeks

Exclusion Criteria

•F506-CL-0404 Part A
•F506-CL-0404 Part B

Locations (12)

Site BE40 Clinique Univ. Saint Luc

Brussels, Belgium

Site FR60 Groupement Hospitalier EST

Bron, France

Site FR61 Hopital Robert Debre

Paris, France

Site DE31 Kliniken der Medizinischen Hoc

Hanover, Germany

Site DE30 Universitätsklin Heidelberg

Heidelberg, Germany

Site PL50 Centrum Zdrowia Dziecka

Warsaw, Poland

Site ES22 H.U. Gregorio Maranon

Madrid, Spain

Site ES20 Hospital Universitario La Paz

Madrid, Spain

Site ES21 Hospital Universitario La Paz

Madrid, Spain

Site ES23 Hospital Universitario La Paz

Madrid, Spain

Key Dates

Start Date

June 24, 2011

Primary Completion Date

April 2, 2017

Completion Date

April 2, 2017

Last Updated

November 1, 2024

Enrollment

ACTUAL participants

Conditions

Heart TransplantationKidney TransplantationLiver Transplantation

Interventions

Tacrolimus granules

DRUG

Tacrolimus capsules

DRUG

Parathyroidectomy After Kidney Transplantation

NCT07415421

HyperparathyroidismKidney Transplantation Recipients

View study

RECRUITING

Multimodal Analysis of Endomyocardial Biopsies

NCT07359690

Heart TransplantationDilated Cardiomyopathy (DCM)+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Parathyroidectomy After Kidney Transplantation

Multimodal Analysis of Endomyocardial Biopsies

Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation