CompletedPhase 4

A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

China55 participantsStarted 2022-01-11

Plain-language summary

The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or kidney transplantation. This study will also observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.

Who can participate

Age range

17 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: * Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study. Exclusion Criteria: * Participant has previously received another organ transplant. * Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score \> 50% in the previous 6 months (only applicable for kidney transplantation recipients). * Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients). * Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients). * Participant receives an ABO incompatible donor organ. * Participant has significant kidney impairment, defined as having serum creatinine ≥ 230 μmol/L (≥ 2.6 mg/dL) prior to transplantation (not applicable for kidney transplantation recipients). * Participant has significant liver disease, defined as having elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBL) levels 3 times the upper value of the normal range prior to transplantation (not applicable for liver transplantation recipients). * Participants with malignancies or a history of malignancy within the last 5 years. * Participant has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active…

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

Pharmacokinetics (PK) of tacrolimus granules in whole blood: area under the blood concentration - time curve for a dosing interval (AUCtau) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in whole blood: AUCtau on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7

PK of tacrolimus granules in whole blood: maximum concentration (Cmax) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in whole blood: Cmax on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7

PK of tacrolimus granules in Whole Blood: Time of Maximum Concentration (Tmax) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in Whole Blood: Tmax on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7

Trial details

NCT IDNCT05152628

SponsorAstellas Pharma China, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-06

View on ClinicalTrials.gov More Liver Transplantation trials

Plain-language summary

Who can participate

Age range

17 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

Pharmacokinetics (PK) of tacrolimus granules in whole blood: area under the blood concentration - time curve for a dosing interval (AUCtau) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in whole blood: AUCtau on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7

PK of tacrolimus granules in whole blood: maximum concentration (Cmax) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in whole blood: Cmax on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7

PK of tacrolimus granules in Whole Blood: Time of Maximum Concentration (Tmax) on Day 1

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1

PK of tacrolimus granules in Whole Blood: Tmax on Day 7

Timeframe: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7