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 range17 Years

SexALL

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…

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

PK of tacrolimus granules in whole blood: Trough blood concentration (Ctrough) on Day 1

Timeframe: Pre-dose on day 1

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 range17 Years

SexALL

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

PK of tacrolimus granules in whole blood: Trough blood concentration (Ctrough) on Day 1

Timeframe: Pre-dose on day 1