TerminatedPhase 4

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

Stopped: Trial will not complete until at least 2025 and evolution of immunosuppressant therapy has made it unlikely that patients will convert from Modigraf to Prograf.

Belgium, France, Germany47 participantsStarted 2011-06-24

Plain-language 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).

Who can participate

Age range

0 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * As all subjects included in this study conform to the exclusion criteria in study F506-CL-0403, hence no specific exclusion criteria are relevant for this study F506-CL-0404 Part B * There are no specific exclusion criteria for this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of Participants with Acute Rejection Episodes

Timeframe: Up to 12 months

Part A; Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)

Timeframe: Up to 12 months

Part A: Severity of BPARs

Timeframe: Up to 12 months

Part A: Patient Survival

Timeframe: Up to 12 months

Part A: Graft Survival

Timeframe: Up to 12 months

Part A: Number of Participants with Adverse Events (AEs)

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)

Part A: Tacrolimus Mean Trough Levels

Timeframe: Day 1, months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)

Trial details

NCT IDNCT01371344

SponsorAstellas Pharma Europe Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-02

View on ClinicalTrials.gov More Heart Transplantation trials

Who can participate

Age range

0 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Number of Participants with Acute Rejection Episodes

Timeframe: Up to 12 months

Part A; Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)

Timeframe: Up to 12 months

Part A: Severity of BPARs

Timeframe: Up to 12 months

Part A: Patient Survival

Timeframe: Up to 12 months

Part A: Graft Survival

Timeframe: Up to 12 months

Part A: Number of Participants with Adverse Events (AEs)

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)

Part A: Tacrolimus Mean Trough Levels

Timeframe: Day 1, months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)