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

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Astellas

Status and phase

Completed
Phase 4

Conditions

Liver Transplantation
Kidney Transplantation

Treatments

Drug: Tacrolimus granules

Study type

Interventional

Funder types

Industry

Identifiers

NCT05153915
2022-002351-19 (Registry Identifier)
F506-CL-0406
CTR20212679 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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.
  • Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.
  • Participants with severe primary disease/complications/poor general condition 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Liver Transplant
Experimental group
Description:
Pediatric participants who undergo de novo allograft liver transplantation receive initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months.
Treatment:
Drug: Tacrolimus granules
Drug: Tacrolimus granules
Kidney Transplant
Experimental group
Description:
Pediatric participants who undergo de novo allograft kidney transplantation receive initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months.
Treatment:
Drug: Tacrolimus granules
Drug: Tacrolimus granules

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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