A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Tacrolimus

Criteria

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 upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer.

• Recipient or donor known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) positive.

• Participant requires systemic immunosuppressive medication for any indication other than transplantation.

• Participants taking or requiring to be treated with medication or substances prohibited by this protocol, such as herbal remedies.

• Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.

• Participants with very low body weight or severe primary disease/complications which may be unsuitable for participating in this study.

• Participant is currently participating in another clinical trial and/or has been taking any other study drug within 1 month prior to screening.

• Participant is unlikely to comply with the visits scheduled in the protocol.